Job Post

VIVIFI MEDICAL is a medtech startup dedicated to improving patient outcomes

and quality of life. Our focus is on ending the need for prostatectomies and

hysterectomies. As a growing company, we are eager to build a team of

talented individuals who share our passion for innovation and improving

healthcare.

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SUMMARY:

The position is responsible for developing, establishing, and maintaining risk

management files for all new product development of permanent implants,

instruments, and packaging. The Design Quality Engineer also participates in

activities to support preclinical and clinical studies.

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ESSENTIAL DUTIES AND RESPONSIBILITIES (includes the following but

other duties may be assigned)

• Facilitate risk management activities throughout all design phases of

new medical devices.

• Use statistical and risk management techniques for design and

manufacturing and medical device industries.

• Perform and sign off on quality activities (risk management, FMEA, test

methods, test method validation, creation of documents, document

review, design history files...) according to project schedule.

• Work with product development and design engineering to perform and

complete product verification and validation activities.

• Apply statistics and process/design excellence tools to establish test

plans and evaluate data and processes.

• Work with product development, design, and supplier quality to identify

CTQs.

• Support development of US FDA submission requirements

• Support all Company initiatives as identified by management and in

support of Quality Management Systems (QMS), Environmental

Management Systems (EMS), and other regulatory requirements. May

serve as coordinator in quality initiatives.

• Support Quality Improvement projects for the site, including formal

quality efforts such as CAPA, NCMR, and audit responses.

• May assist with complaint analysis and support of post clinical study

surveillance.

• Complies with US Food and Drug Administration (FDA) regulations,

other regulatory requirements, Company policies, operating procedures,

processes, and task assignments.

• Maintains positive and cooperative communications and collaboration

with all levels of employees, customers, contractors, and vendors.

• Performs other related duties and responsibilities, as assigned.

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QUALIFICATION REQUIREMENTS

• BS in Engineering (preferred), science or technical field

• Experience in related areas, R&D or Manufacturing may also be

applicable if experience includes work responsibilities listed above.

• Working knowledge of various medical device development cycles.

• Minimum (7) seven years’ experience in medical device design,

manufacturing or quality engineering position (medical implant and/or

anastomosis device experience preferred)

• Previous experience working in a cross-functional team environment.

• Experience with analytical tools and methods, including statistics

(Minitab preferred), DOE, and the use of computer software packages

related to design, development, and manufacturing.

• Experience with FDA requirements 21 CFR 820, knowledge of

regulations such as GLP, GMP, ISO 13485 and ISO 14971, as well as

other international regulatory requirements, preferred.

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ADDITIONAL DETAILS

• This position will be hybrid with travel required to support preclinical and

clinical studies.

• Flexibility on part-time initial onboarding phase before transitioning to a

full-time role.

About the company: Over 3 billion people worldwide grapple with devastating

reproductive disorders: Benign Prostatic Hyperplasia (BPH), Prostate Cancer

(PCa), infertility, uterine fibroids, endometriomas and polycystic ovarian

syndrome (PCOS). These conditions carry a staggering healthcare burden

exceeding billions of dollars annually. Current treatments heavily rely on

hormone manipulation or surgical tissue resection, leading to side effects that

decrease patient compliance and quality of life. Vivifi Medical offers a

groundbreaking alternative – a minimally invasive surgical approach that could

change the very way we fight reproductive disorders. We strategically redirect

blood flow, starving problematic tissues of the hormones that fuel their growth.

This means potential cures without organ-destroying procedures or long-term,

side-effect-laden drugs. We are targeting BPH and hypogonadism as a

beachhead indication to support the development of our technology for use in

other reproductive disorders.

Vivifi Medical is based out of Oregon Biosciences Incubator (OBI) at Portland

OR, with additional site at TMCi Center for Device Innovation in Houston, TX.

If you are a motivated and creative individual with a passion for improving

patient outcomes and quality of life, we encourage you to apply for this exciting

opportunity. Please submit your resume highlighting your qualifications and

experience. We are an equal opportunity employer and encourage candidates

from diverse backgrounds to apply.

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If interested, send your resume to: info@vivifimedical.com

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