Product Development Engineer II (Medical Devices)

Location: On-site five days a week at the San Diego office, California - High Bluff, United States.

Base pay: $85,000–$100,000 annually, excluding bonus and benefits.

Company

hirify.global develops and manufactures diabetes technology, including the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology.

What you will do

• Contribute to the development, documentation, testing, analysis, troubleshooting, and debugging of medical devices, fixtures, and data collection systems.
• Design medical devices, fixtures, components, and assemblies in SolidWorks, including prototyping, tolerance analysis, and manufacturability assessment.
• Manage design verification and validation activities, including work instructions, test protocols, reports, and associated documentation.
• Investigate design non-conformances and assembly process issues through root cause analysis and troubleshooting.
• Design, qualify, and document fixtures, equipment, CNC-machined components, assembly processes, and pilot assembly lines.
• Plan experiments, perform statistical process analysis, review validation documentation, select reliable components, and coordinate external testing with vendors.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related field, or an equivalent combination of education and applicable experience.
• At least 2 years of product development experience in a heavily regulated industry; medical device experience is preferred.
• Ability to work effectively in a team and communicate technical information to varying organizational levels.
• Experience or exposure to testing methodology and data collection in a development environment.
• Ability to consolidate, evaluate, and present information to assert ideas and persuade others, and to adapt opinions based on new information.
• Excellent written communication skills and experience with Microsoft Office.
• Ability to use statistical analysis techniques and tools to summarize data and support conclusions.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP).

Nice to have

• Ability to create and modify engineering models and drawings in SolidWorks.
• Working knowledge of QSRs, ISO 14971, IEC 60601 series, and other applicable regulations.
• Experience with medical device design, product development, and process development.

Culture & Benefits

• On-site work five days per week at the San Diego office.
• Medical, dental, and vision benefits available from the first day, plus health savings and flexible spending accounts.
• Eleven paid holidays, at least 20 days of paid time off with accrual starting on day one, a 401(k) with company match, and an Employee Stock Purchase plan.
• Employment is contingent on a drug test, excluding marijuana, and a background check including criminal history review.
• Applicants must be authorized to work for any U.S. employer; visa sponsorship or transfer is not available.

Hiring process

• The position remains posted until a final candidate is selected or a sufficient number of applications is received.
• Qualified applicants with arrest or conviction records will be considered under applicable state and local Fair Chance laws.