About
MEET OUR TEAM
PRESIDENT AND CEO
Jeffrey M. Closs
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Mr. Closs brings proven leadership in medical devices, health policy, and technology to the Ancora Heart team. He has dedicated his career to working at the intersections of change to promote innovative, life-changing solutions. He has extensive experience founding new ventures (Benu), driving a successful IPO (Perclose), and having leadership roles at Fortune 500 companies (Fox Hollow, Edwards, Guidant, Bentley). Formerly a director at Nellix Endovascular, which was acquired by Endologix, and BioIQ, a health tech company, he is also an adjunct professor at Stanford University Center for Health Policy and the former president of the St. Raymond School Board. Mr. Closs holds an MBA from Emory University and a BA from the University of California, Los Angeles.
CHIEF TECHNICAL OFFICER
Russel Sampson
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A champion for the development of minimally invasive surgical systems, Mr. Sampson brings a proven track record of invention (over 80 U.S. international patents) to his position at Ancora Heart. Leveraging his deep experience with CE and PMA approvals, commercialization, profitability and acquisition for companies such as Cytyc, Novacept, Abbott Laboratories, Space Systems/Loral and Ford Aerospace, he is responsible for our core technology, intellectual property and product development efforts. Mr. Sampson is the co-founder of Sierra Surgical Technologies (SST) and holds a BS in Mechanical Engineering (AMES) from the University of California, San Diego.
CHIEF COMMERCIAL OFFICER
Mark Miles
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Mr. Miles brings 25 years of experience scaling medical technology companies to his position as chief commercial officer (CCO) of Ancora Heart, including his most recent post as CCO of Terumo Aortic in Glasgow, Scotland. In that role, he was responsible for global sales and marketing, custom solutions, portfolio strategy and expansion into new markets, helping guide the company during a period of significant growth.
Prior to his time at Terumo Aortic, Mr. Miles served as senior director of commercial strategy at Invuity, where he played a key role in driving adoption of their core product lines across key surgical specialties throughout the United States. He was instrumental in facilitating significant growth through the company’s eventual IPO in 2015. Previously, Mr. Miles held positions of increasing responsibility at Medtronic, serving as director of global marketing of the Endovascular Business Unit. He began his career at Eli Lilly and Company, serving various commercial leadership roles during his eight-year tenure. Mr. Miles received an MBA from Pepperdine University and a BS in health sciences from James Madison University.
VICE PRESIDENT OF BIOSTATISTICS AND CLINICAL DATA MANAGEMENT
Christine Tjossem
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Ms. Tjossem brings a 35-year track record of successful growth and leadership in biostatistics and data management to her position at Ancora Heart. Her experience includes key roles establishing and managing biostatistical and data management efforts at some of the world’s leading clinical research and medical device organizations, including Medtronic, Boston Scientific, St. Jude and Berlin Heart. Ms. Tjossem began her career working in medical research for Mayo Clinic in Rochester, Minnesota. As Vice President of Biostatistics and Data Management, Ms. Tjossem is responsible for all facets of her team’s success in advising and implementing appropriate techniques and methods for statistical and data management areas. In addition to managing these line-of-business functions, Ms. Tjossem’s vast breadth and depth of experience allows her to make significant contributions to the company’s overall business, regulatory and clinical strategy. Christine received her Bachelor of Science degree in Statistics from Iowa State University.
VICE PRESIDENT AND GM, INT’L CLINICAL, REGULATORY AND THERAPY DEVELOPMENT
Michael Zapien
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Drawing on his expertise in transitioning innovative medical devices from the developmental stage to commercial success at several emerging startups (Elixir, Nanostim), Mr. Zapien leads our clinical research. Previously the Director of Clinical and Medical Affairs at CardioDx, Inc., he also has clinical and commercial experience at Medi-Globe, Silk Road Medical, Abbott Vascular, and Guidant Corp. Mr. Zapien is a certified clinical researcher with a MS from the University of Maryland and a BS from San Francisco State University.
VICE PRESIDENT OF
STRATEGIC INITIATIVES
Bart Beasley
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A veteran of introducing early-stage and ground-breaking therapies to physicians, Mr. Beasley brings over 25 years of experience in healthcare marketing to Ancora Heart. By building partnerships with the clinical community, gathering first-hand insights towards procedure and product development, and enhancing clinical trial patient education and recruitment, he has helped drive the rapid growth of multiple revolutionary therapies and new therapeutic categories. Mr. Beasley served as Vice President of Marketing at Avinger, drove market development at Transcend Medical (acquired by Alcon), was Director of Marketing at Fox Hollow (acquired by ev3), and began his career at Perclose (acquired by Abbott). Mr. Beasley holds an MBA from IESE Business School in Barcelona, Spain and a BS in Economics from Santa Clara University.
VICE PRESIDENT OF REGULATORY AFFAIRS
AND QUALITY ASSURANCE
Michael Fritz
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Mr. Fritz comes to Ancora Heart with decades of medical device industry experience including strategic leadership, management, operational, and hands-on roles in regulatory affairs, clinical research, quality assurance, and engineering. His career includes roles with small start-ups (Synapse Biomedical and Cyberkinetics) and larger companies (Medtronic, Boston Scientific, and Guidant) developing class III implantable devices and class II minimally invasive devices in diverse fields including interventional cardiology, cardiac electrophysiology, neurology, pulmonary/respiratory, laparoscopic surgery, neurosurgery, rehabilitation medicine, and neuroprosthetics. Mr. Fritz holds an MS degree in software engineering from the University of St. Thomas and a bachelor of electrical engineering degree from the University of Minnesota.
Meet Our Board of Directors
CHAIRMAN
Bob Croce culminated 12 years as Company Group Chairman through a 36-year career at Johnson & Johnson. Beginning in 1968, Mr. Croce held a series of senior positions beginning as a Sales Representative for Ortho Pharmaceuticals where he was later named Vice President of Marketing. Prior to that, he served as Worldwide Franchise Chairman of Cordis and Ethicon Endo-Surgery. In 1985, Mr. Croce was named Vice President of Business Development at McNeil. He was later transferred to Ethicon, Inc., where he served as Group Vice President, and was later named President in 1990. In 1992, he was promoted to Worldwide President of Ethicon Endo-Surgery.
SAVITR CAPITAL
Savitr Capital was founded by Andrew Midler in 2008. Prior to Savitr Capital, Andrew founded Standard Pacific Capital in 1995. The investment management firm launched with $75 million of assets and grew to over $5 billion. Until 2005, Midler managed the firm’s Global Long/Short Equity Fund for Standard Pacific’s flagship product. He also supervised the firm’s credit opportunities, commodity, quantitative, and Japan long/short equity strategies. He served as the CIO and CEO of the firm from 1995 to 2007 before selling his majority ownership interest in the firm in December 2007. Prior to founding Standard Pacific, Midler was the Director of Equity Portfolio Management at CS First Boston, a global institutional money management firm. Previously, he managed a significant portion of the global hedge fund, Odyssey Partners. From 1986 through 1993, he worked at Fidelity Investments where he was Portfolio Manager of the Fidelity Convertible Securities Fund, Fidelity Equity Income II Fund and Fidelity Growth & Income Fund.
LCP VENTURES
Lew Pell is one of the most prolific and successful medical technology investors. Since 1975, Pell has been the lead investor and co-founder of 24 different medical device manufacturers, eight of which have been sold for a collective net gain of $1.6 billion. Pell’s founding of medical technology companies began in 1975, when he and Katsumi Oneda co-founded Machida America to sell flexible endoscopes. In 1979, he created Pentax Precision Instruments and sold it to Asahi Optical eleven years later. Over a span of 15 years, Pell co-founded various medical device companies including: American Endoscopy (acquired by Medtronic), Heart Technology (acquired by Boston Scientific), InStent (acquired by Medtronic), and Vision Sciences. He was also co-founder of Biosense (acquired by Johnson & Johnson), Influence, Inc. (acquired by American Medical Systems), and Disc-O-Tech (sold to Kyphon).
MADORRA, INC.
Beverly Huss is a medical device entrepreneur, board director and mentor who brings with her more than 20 years’ experience as a leader of both large corporations and start-up companies in the medical device space. She is currently Executive Chair of Madorra, Inc., a women’s health company focused on improving quality of life after menopause. Ms. Huss was co-founder and CEO of Pagonia Medical. Prior to founding Pagonia, she was president and CEO of Qool Therapeutics, Inc., a tissue preservation company. Previously she was co-founder and CEO of Vibrynt, Inc., a company that developed a novel minimally invasive therapeutic device for treatment of morbid obesity. Prior to this, Ms. Huss was with Santa Clara, California-based Guidant since 1986, fulfilling a variety of executive roles within the company’s various medical device divisions. She managed the worldwide Endovascular Solutions business as President and quadrupled worldwide revenues to $150 million for the carotid and peripheral vascular business in four years. In addition, she built Guidant’s coronary stent business to $1B with 90% gross margins.
PRESIDENT & CEO
Mr. Closs brings proven leadership in medical devices, health policy, and technology to the Ancora Heart team. He has dedicated his career to working at the intersections of change to promote innovative, life-changing solutions. He has extensive experience founding new ventures (Benu), driving a successful IPO (Perclose), and having leadership roles at Fortune 500 companies (Fox Hollow, Edwards, Guidant, Bentley). Formerly a director at Nellix Endovascular, which was acquired by Endologix, and BioIQ, a health tech company, he is also an adjunct professor at Stanford University Center for Health Policy and the former president of the St. Raymond School Board. Mr. Closs holds an MBA from Emory University and a BA from the University of California, Los Angeles.
WORK WITH US
It has come to our attention that an unknown entity is impersonating our organization and extending illegitimate job offers via email, purportedly in an attempt to defraud intended applicants.
Please be advised that these email solicitations appear to be part of a fake job scheme. For additional information, please see https://www.fbi.gov/contact-us/field-offices/elpaso/news/press-releases/fbi-warns-cyber-criminals-are-using-fake-job-listings-to-target-applicants-personally-identifiable-information.
Authorized Ancora Heart employees will reach out to potential candidates directly via telephone or email from ancoraheart.com but will never issue questionnaires or request personal information. Job offers will only be extended after a thorough interview process and multiple interactions with Ancora Heart staff members. When communicating, please be very cautious of fictitious email addresses.
Ancora Heart is looking for talented professionals to join our growing team. We value creativity, drive, accountability, and the ability to work collaboratively with one another. If you thrive in a fast-paced setting and are passionate about changing the way heart failure is treated, consider the following opportunities:
Manufacturing and Process Engineers
PURPOSE OF JOB:
- Support the company’s transition from clinical stage to commercialization within manufacturing, process, and automation engineering. Evaluate and optimize existing processes, design & implement custom fixtures, tooling, automated equipment within and outside a cleanroom environment. Work closely with the R&D, Operations, and Quality Systems staffs to improve existing processes and perform process validations. This hands-on role requires accountability and the ability to work with minimal supervision.
MAJOR DUTIES AND RESPONSIBILITIES:
- Design, document, assemble, and qualify production assembly / test / inspection fixtures and equipment.
- Specify, procure and implement off the shelf automated and semi-automated equipment
- Design, develop and implement custom equipment as-needed.
- Create verification or validation protocols, execute studies and/or tests, and author and release subject reports.
- Perform characterization studies and Design of Experiments (DoE).
- Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
- Write and maintain manufacturing documentation including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.
- Maintain compliance with Ancora Heart’s quality systems including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).
- Train operators on new processes, tools, and equipment.
- Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.
- Assure product and process quality by designing testing methods; testing sub-assemblies, finished product and process capabilities.
- Develop, qualify and implement processes to improve manufacturability.
- Complete projects and tasks in a timely manner consistent with corporate objectives. Keep manager informed of changes in work schedule and/or workload.
- Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.
- Support company goals and objectives, policies and procedures.
- Perform other duties as assigned.
EDUCATION REQUIREMENTS:
- Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline.
EXPERIENCE REQUIREMENTS:
- Minimum 5 years of related experience
OTHER QUALIFICATIONS:
- Knowledge of FDA, QSR and MDR regulations and relevant FDA Guidance and ISO standards.
- Strong background in IQ/OQ/PQ,
- SPC
- PLC programming, operation
- Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges.
- Strong background in DFMEA, SHA, test methods, quality inspection methodology, report writing.
- Flexibility to perform a wide range of activities in parallel.
- Strong communication skills, sound judgement
- Willingness and ability to work independently and in teams
- Experienced with Mini-Tab and SolidWorks
- Skilled in all Microsoft Office products, including Excel, Word, and PowerPoint.
Manufacturing and Process Engineers
PURPOSE OF JOB:
- Support the company’s transition from clinical stage to commercialization within manufacturing, process, and automation engineering. Evaluate and optimize existing processes, design & implement custom fixtures, tooling, automated equipment within and outside a cleanroom environment. Work closely with the R&D, Operations, and Quality Systems staffs to improve existing processes and perform process validations. This hands-on role requires accountability and the ability to work with minimal supervision.
MAJOR DUTIES AND RESPONSIBILITIES:
- Create verification or validation protocols, execute studies and/or tests, and author and release subject reports to support the Master Validation Plan (MVP).
- Document, assemble, and qualify production assembly / test / inspection fixtures and equipment.
- Specify, procure and implement off the shelf automated and semi-automated equipment
- Implement custom equipment as-needed.
- Assist in characterization studies and Design of Experiments (DoE).
- Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
- Write and maintain manufacturing documentation including material and component specifications, work instructions, TMVs, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.
- Maintain compliance with Ancora Heart’s quality systems including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).
- Train operators on new processes, tools, and equipment.
- Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.
- Assure product and process quality by designing testing methods; testing sub-assemblies, finished product and process capabilities.
- Develop, qualify and implement processes to improve manufacturability.
- Complete projects and tasks in a timely manner consistent with corporate objectives. Keep manager informed of changes in work schedule and/or workload.
- Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.
- Support company goals and objectives, policies and procedures.
- Perform other duties as assigned.
EDUCATION REQUIREMENTS:
- Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline
EXPERIENCE REQUIREMENTS:
- 5 – 9+ years of related experience
OTHER QUALIFICATIONS:
- Knowledge of FDA, QSR and MDR regulations and relevant FDA Guidance and ISO standards.
- Background in IQ/OQ/PQ,
- Quality Engineering experience capability analysis, SPC, CAPA, metrics, etc.
- Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges.
- Background in DFMEA, Process Flowcharting, test methods, quality inspection methodology, report writing.
- Flexibility to perform a wide range of activities in parallel.
- Strong communication skills, sound judgement
- Willingness and ability to work independently and in teams
- Experienced with Mini-Tab and SolidWorks
- Skilled in all Microsoft Office products, including Excel, Word, and PowerPoint.
Product Development & Manufacturing Engineer
PURPOSE OF JOB:
- Support the company’s transition from clinical stage to commercialization within product design and improvements for manufacturability, DV testing, manufacturing, process, and automation engineering. Evaluate and optimize existing designs and processes, provide design updates as-needed, design & implement custom fixtures, tooling, automated equipment within and outside a cleanroom environment. Work closely with the R&D, Operations, and Quality Systems staff to improve existing processes and perform process validations. This hands-on role requires accountability and the ability to work with minimal supervision. This is an on-site position.
MAJOR DUTIES AND RESPONSIBILITIES:
- Update product design as-needed to support high volume manufacturing
- DV tests, fatigue testing
- Design, document, assemble, and qualify production assembly / test / inspection fixtures and equipment.
- Specify, procure and implement off the shelf automated and semi-automated equipment
- Design, develop and implement custom equipment as-needed.
- Create verification or validation protocols, execute studies and/or tests, and author and release subject reports.
- Perform characterization studies and Design of Experiments (DoE).
- Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
- Write and maintain manufacturing documentation including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.
- Maintain compliance with Ancora Heart’s quality systems including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).
- Train operators on new processes, tools, and equipment.
- Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.
- Assure product and process quality by designing testing methods; testing sub-assemblies, finished product and process capabilities.
- Develop, qualify and implement processes to improve manufacturability.
- Complete projects and tasks in a timely manner consistent with corporate objectives. Keep manager informed of changes in work schedule and/or workload.
- Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.
- Support company goals and objectives, policies and procedures.
- Perform other duties as assigned.
EDUCATION REQUIREMENTS:
- Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline.
EXPERIENCE REQUIREMENTS:
- Minimum 5 years of related experience
OTHER QUALIFICATIONS:
-
- Experience with NiTi components, SN testing and fatigue testing desired.
- Knowledge of FDA, QSR and MDR regulations and relevant FDA Guidance and ISO standards.
- Strong background in IQ/OQ/PQ,
- SPC
- PLC programming, operation
- Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges.
- Strong background in DFMEA, SHA, test methods, quality inspection methodology, report writing.
- Flexibility to perform a wide range of activities in parallel.
- Strong communication skills, sound judgement
- Willingness and ability to work independently and in teams
- Experienced with Mini-Tab and SolidWorks
- Skilled in all Microsoft Office products, including Excel, Word, and PowerPoint.
Ancora Heart offers a competitive compensation and benefits program as well as a progressive work environment. We are an equal opportunity employer. If you or someone you know might be interested in this position, please submit a resume and an introductory email to careers@ancoraheart.com