Engineer I, Medical Device

Engineer I, Medical Device Full-Time (On-site)

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. This allows individuals with limited or no training to easily and intuitively perform an injection on themselves or others.

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. The successful candidate will be well-versed with the product development process and will work on a small team to develop and drive the life-saving technology through its lifecycle, including FDA approval, pre-production, commercial productization, volume ramp, continuous process improvement, and post-market assessment. Prior experience with medical device development, manufacturing, and testing is a must. Experience working on combination products and in start-ups/ early stage companies is a plus.

Location:

Portsmouth, NH (On-site).

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. 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 Skills 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. 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. 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.

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: 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:

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.