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Mechanical Design Engineer Jobs

Company

Pirouette Medical
Address , Portsmouth, 03801, Nh
Employment type
Salary $74,000 - $100,000 a year
Expires 2023-10-06
Posted at 9 months ago
Job 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 pass away 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 which we are looking to explore as well.

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 you to help us bring healthcare into the hands of patients everywhere.

Position Description

This is an opportunity to join as a Mechanical Design Engineer I at a venture backed Medical Device organization. The successful candidate will be supporting our medical device design and product development efforts, 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.

Responsibilities

  • Interfaces with strategic partners and corporate groups in addition to consultants, contractors and vendors.
  • Developing and executing test protocols to satisfy design requirements and product specifications and collaborate with in-house and external collaborators for verification/validation studies.
  • Works as a core team member of the product development team and will work closely with all functional teams to coordinate activities.
  • Performs design and development of novel drug delivery and associated technologies.

Required Skills and Experience

  • 1+ year/s of experience in a relevant engineering position. (New grads welcome).
  • Proficiency in technical drawings, and familiarity with GD&T.
  • Bachelors or Masters degree in Mechanical, Biomedical Engineering, or similar.
  • 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.
  • Proficiency as a maker (3D printing, laser cutting, lathe etc).
  • Proficiency in Solidworks, especially in analysis and simulations.

Desired Experience

  • 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.
  • Strong background and knowledge in medical device manufacturing.Experience in engaging regulatory professionals for navigating the early stages of the product development process through FDA regulatory submission.

Values

  • Problem-Solver
  • Continuous Learning
  • Self-starter
  • Intellectual Curiosity
  • Business Development Mindset
  • Independent Thinker
  • Hands-on Practitioner
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.
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.