Process Development Engineer

Posted 6 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
103K-171K Annually
Senior level
Healthtech
The Role
Develops, validates, and industrializes medical device manufacturing processes at external suppliers from concept through commercial launch. Leads process characterization, DOE, statistical analysis, validation, engineering builds, readiness reviews, and manufacturing documentation. Collaborates with contract manufacturers and suppliers to resolve technical issues, monitor deliverables, and ensure manufacturing readiness. Requires at least five years of medical device engineering experience and expertise in process development, supplier collaboration, and IQ/OQ/PQ validation.
Summary Generated by Built In
Work Flexibility: Onsite

Join a team focused on bringing innovative medical devices from concept into commercial production through strong manufacturing execution and supplier collaboration. In this role, you will work closely with contract manufacturers, component suppliers, and cross-functional teams to develop, validate, and industrialize manufacturing processes that support successful product launches. This position offers the opportunity to lead technical activities across the product development lifecycle while driving manufacturing readiness at external production partners.

What You Will Do

  • Lead development of manufacturing processes at external suppliers for new product introduction programs, from concept through commercial launch.

  • Design and execute process characterization studies, Design of Experiments (DOE), and statistical analyses to establish process capability, critical parameters, and operating windows.

  • Develop and coordinate manufacturing industrialization plans, including engineering builds, validation activities, readiness reviews, and commercialization milestones.

  • Drive supplier technical execution by leading technical reviews, monitoring engineering deliverables and schedules, and resolving manufacturing and process-related issues.

  • Create and maintain validation and manufacturing documentation, including IQ/OQ/PQ protocols, validation reports, process flows, equipment specifications, work instructions, and risk assessments.

What You Will Need

Required:

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.

  • Minimum 5 years of engineering experience within the medical device industry.

  • Experience developing manufacturing processes for new products.

  • Experience working directly with external suppliers or contract manufacturers.

  • Experience with process characterization, Design of Experiments (DOE), statistical analysis, and manufacturing process validation (IQ/OQ/PQ).

Preferred:

  • Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products.

  • Experience with manufacturing technologies such as extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging.

  • Experience with manufacturing industrialization, technology transfer, Design for Manufacturability (DFM), PFMEA, APQP, PPAP, Minitab, or JMP.

  


United States of America Pay Ranges:

US15: $102,700 - $171,100 USD Annual

  


Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Skills Required

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline
  • Minimum 5 years of engineering experience within the medical device industry
  • Experience developing manufacturing processes for new products
  • Experience working directly with external suppliers or contract manufacturers
  • Experience with process characterization, Design of Experiments (DOE), statistical analysis, and manufacturing process validation, including IQ/OQ/PQ
  • Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products
  • Experience with extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging
  • Experience with manufacturing industrialization, technology transfer, Design for Manufacturability (DFM), PFMEA, APQP, PPAP, Minitab, or JMP

Inari Medical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.

  • Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
  • Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
  • Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.

Inari Medical Insights

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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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