Mechanical Design Engineer

Full Time Mechanical Design Engineer at Pirouette Medical (United States) BEAMSTART Jobs

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Mechanical Design Engineer

Pirouette Medical United States

Date Posted : 02 Aug, 2023

Work Location : Boston, United States

Salary Offered : $74000 $100000 yearly

Job Type : Full Time

Experience Required : No experience required

Remote Work : No

Stock Options : Yes

Vacancies : 1 available

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 next Mechanical Design Engineer to work alongside our CTO. You’ll have ownership over our auto-injector’s assembly process from start to finish.

If you’re a self-described hands-on engineer with initiative and a knack for problem solving, you’ll fit right in.

Position Description

This is an opportunity to join as a Mechanical Design Engineer at a venture-backed Medical Device organization. The successful candidate will be a hands-on product development engineer that will support our medical device design and product development efforts.

The successful candidate will be well-versed with the product development process and will work on a small team to develop and drive life-saving technology towards FDA approval.

Prior experience working in start-ups / early stage companies is a plus.

Essential Duties

• 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.
• Developing and executing test protocols to satisfy design requirements and product specifications and collaborate 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 Education and Experience

• Bachelors 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.
• Knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e.

21 CFR 820 / ISO13485 quality system requirements, ISO 11608, and other relevant global standards).

• Experience developing device and combination product devices from research or conception through registration and launch.
• Experience in engaging regulatory professionals for navigating the product development process through FDA regulatory submission, scaling manufacturing, and post-market surveillance.
• Experience with drug-device combination products, 510(k), NDA (e.g., 505(b)(2)), and / or PMA submission process (or global equivalent) for Class I and / or Class II and / or Class III medical devices.
• 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.

Skills and Abilities

• 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.
• Understanding of new product introduction, design, and development of extruded, molded and / or assembled device products.
• Proficiency as a maker (3D printing, laser cutting, lathe, etc.) is a plus!

Location

Portsmouth, NH (On-site).

Compensation

Salary Range : $74K - $100K, pending experience. 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 : Yes, 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.

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