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Engineer I, Medical Device

Pirouette Medical • Boston, MA, United States • $200k - $250k / year • 1m ago

Engineer I, Medical Device

Pirouette Medical, United States

Date Posted: 31 Oct, 2022

Work Location: Boston, United States

Salary Offered: $60,000 — $80,000 yearly

Job Type: Full Time

Experience Required: No experience required

Remote Work: No

Stock Options: Yes

Vacancies: 1 available

Company Description:

At Pirouette, we have developed a low-profile, disk-shaped, rugged injection device (auto-injector) with a patient-centric focus on affordability, portability, and usability. The patented device, based on extensive patient input, is designed to make administering an injection as easy as pushing a button.

Position Description:

This is an opportunity to join a dynamic team as an Engineer I, Medical Device at a venture-backed Medical Device organization, reporting directly to the CTO. The successful candidate will drive key activities throughout the development phases of the combination product as well as transitioning the design to large-volume manufacturing, and facilitate the deliverables to support regulatory filing, product launch, and post-market surveillance.

Key Responsibilities:

Performs design and development of novel drug delivery and associated technologies.
Works as a core team member of the product development team and will work closely with all functional teams to coordinate activities.
Develops and executes test protocols to satisfy design requirements and product specifications.
Collaborates with in-house and external collaborators for verification/validation studies.
Interfaces with strategic partners and corporate groups in addition to consultants, contractors, and vendors.
Other duties as assigned, according to the changing needs of the business.

Required Skills and Experience:

Bachelor's in Mechanical, Biomedical Engineering, or similar.
Proficiency in CAD, preferably SolidWorks, especially in analysis and simulations.
Proficiency in technical drawings, and familiarity with GD&T.
Excellent communication skills, both oral and written.
A willingness and ability to wear multiple hats, operate independently, and as part of a team.
Understanding of new product introduction, design, and development of device products.
Knowledge of regulatory and compliance requirements of device design controls.
Experience developing device and combination products from research through registration and launch.
Experience with drug-device combination products, 510(k), NDA, and/or PMA submission process.
Demonstrated understanding and experience in the medical device industry.

Preferred Experience:

Proficiency as a maker (3D printing, laser cutting, lathe, etc.).

Compensation:

Salary Range: $60K - $80K, pending experience. Benefits: Medical, Dental, Vision, Disability, Life. PTO: Discretionary.

Other:

Pirouette Medical is an equal opportunity employer, meaning we consider applicants for employment and make employment decisions without unlawful regard to any protected characteristic under applicable law.