Quality Engineer

Company Description:

We make injections as easy as pushing a button.

43 million Americans are at risk of life-threatening allergic reactions, but only half of those prescribed an EpiPen can use it correctly and 5 people die every day due to failure. Here at Pirouette Medical (YC S21) we’ve developed a patented auto-injector that is as easy to use as pushing a button! Our auto-injector is also diversely applicable to additional drug applications.

We’ve just received our Series A from investors such as Y-Combinator, Safar Partners, Liquid 2 Ventures, and Helium-3 Ventures including many others. We’re looking forward to bringing on our first Quality Engineer to work together with our Director of Quality Systems.

Position Description:

This is an opportunity to join as a Quality Engineer at a venture backed Medical Device organization. The successful candidate will be a hands-on engineer supporting our Director of Quality Management. They will develop, implement, and maintain procedures, methods, and documentation related to upholding the quality assurance of our auto-injector. Prior experience working in start-ups/ early stage companies is a plus.

Responsibilities:

• Manage the progress of activities related to non-conformance, CAPA, and customer concerns.

• Interfaces with strategic partners and corporate groups in addition to consultants, contractors and vendors for equipment management and calibration.

• Develop and write test methods, standard operating procedures.

• Review third party quality documentation, test methods, process flows, FMEAs, and all other relevant documentation.

• Assist the Director of Quality Systems with recordkeeping and document generation.

• Works as a core team member of the quality team and will work closely with all functional teams to coordinate activities.

Required Skills and Experience:

• 0-5 years of experience in a relevant engineering position. (New grads welcome).

• Bachelors or Masters degree in Biomedical Engineering, or similar.

• Proficiency in MS Office, especially Excel.

• High level of attention to detail

• Communicates ideas, information, and recommendations clearly, effectively, and frequently (oral and written).

• A willingness and ability to wear multiple hats, operate independently, and as part of a team in a small organization setting where a self-starter personality is key.

Desired Experience:

• Familiarity with any Electronic Management System (e.g. Greenlight Guru, Master Control)

• Experience working in the medical device, pharmaceutical, automotive, or consumer goods manufacturing industry or similar.

• Experience in engaging regulatory professionals for navigating the early stages of the product development process through FDA regulatory submission.

• Experience with combination products, 510(k), NDA, and/or PMA submission process (or global equivalent) for Class I and/or Class II and/or Class III medical devices, is a plus.

• Demonstrated understanding and experience of working in the medical device industry, familiarity with product development procedures, design control documentation and FMEA, quality assurance and regulatory standards.

Location:

• Portsmouth, NH (On-site).

Compensation:

Salary Range: $60-80K DOE Benefits: Medical, Dental, Vision, Disability, Life. PTO: Discretionary: Similar to unlimited vacation policies, employees using discretionary PTO don’t have a designated number of paid time off hours. Instead, employees collaborate with their direct supervisors to determine what vacation days they can use and when. Stock Options: Potential, pending experience.

Other

Third Party and External Recruiters will not be entertained.

Pirouette Medical is an equal opportunity employer, meaning we consider applicants for employment and make employment decisions without unlawful regard to sex, race, color, religion, citizenship, national origin, ancestry, sexual orientation, age, marital or domestic partner/civil union status, military service, veteran status, physical or mental disability, or any other protected characteristic under applicable law.