Process 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 a pioneer Process 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 a full-time position and an individual contributor role working on-site in Portsmouth, NH. The successful candidate will be reporting to the CTO to work on documenting and standardizing the existing manual assembly process for Pirouette’s novel auto-injector. The candidate will have the opportunity to own the process and directly oversee the transition of the assembly process from manual to semi-automated and finally fully-automated. Working within a quality system the candidate will interface with suppliers to ensure the specifications and requirements are met.

Essential Duties

• Generate work instructions for the existing assembly processes and incorporate revisions when needed

• Identifying potential failure points within the existing assembly process and future processes and assessing the risk of those failures

• Make recommendations for improvement towards a semi-automated assembly process, and then an automated assembly process.

• Design/test/build assembly fixtures with emphasis on safety, efficiency and scalability.

• Oversee installation, implementation, assembly, and maintenance of fixtures and equipment.

• Collaborate with in-house and external collaborators to satisfy design requirements and product specifications.

• Work directly with equipment suppliers to support assembly specifications and requirements.

• Work with Quality and Engineering team to draft PFMEA to ensure failure modes are identified and mitigated.

Required Education and Experience

• Bachelors in Mechanical, Biomedical Engineering, or similar.

• Proficiency in CAD, preferably SolidWorks, especially in analysis and simulations.

• Proficiency in technical writing

• Preferred: Medical Device assembly or design experience

• Preferred: Installation Qualification, Operational Qualification, Process Qualification

• Preferred: Cleanroom experience

Skills and Abilities

• Collaborative

• Self-starter

• Hands-on Engineer

• Intellectual Curiosity

• Problem-Solver

• Continuous Learning

• Independent Thinker

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.