Senior Staff R&D Process Development Engineer

Work Flexibility : Onsite

Stryker Inari is seeking a skilled R&D Development Engineer to support the scale-up and manufacturing readiness of an innovative electro-mechanical medical device integrating precision components and injection-molded parts. This role focuses on developing optimizing and validating robust manufacturing processes to ensure product quality reliability and regulatory compliance.

This role is fully onsite role in Irvine CA with the expectation to be in office 5 days a week.

Check out our product portfolio : Stryker Inari

What you will do :

Develop optimize and document manufacturing processes for electro-mechanical assemblies and injection-molded or precision-machined components.

Support design transfer from R&D to manufacturing ensuring manufacturability and cost-effectiveness.

Create process flow diagrams work instructions PFMEAs and validation protocols (IQ / OQ / PQ).

Collaborate with suppliers on injection molding precision machining and subassembly processes including supplier qualification and capability assessment.

Design and implement fixtures tools and test setups to support assembly and inspection.

Conduct root cause analysis and implement corrective actions for process issues to improve yield reliability and throughput.

Ensure all processes comply with ISO 13485 FDA 21 CFR Part 820 and internal quality system requirements.

Contribute to documentation for regulatory submissions and manufacturing readiness.

What you need :

Bachelors or Masters degree in Mechanical Engineering Mechatronics or Biomedical Engineering.

6 years of experience

Preferred Qualifications :

Process development or manufacturing engineering experience in the medical device industry preferably in electro-mechanical or intelligent therapeutic systems (e.g. thrombectomy cardiac or neurovascular devices).

Proven experience developing and scaling complex electro-mechanical assemblies including sub-systems involving motors sensors pumps PCBs firmware and disposable interfaces.

Experience in medical system integration especially involving consolecatheter interfaces sensor feedback loops or closed-loop control systems.

Demonstrated success supporting new product introduction (NPI) and design transfer from R&D into pilot or full-scale production environments.

Strong knowledge of mechatronic system integration including hardwarefirmware interface validation system calibration and electro-mechanical testing.

Hands-on experience in process design DOE root cause analysis SPC and validation (IQ / OQ / PQ) of electromechanical manufacturing and test processes.

Familiarity with PCB and wiring assembly processes electrical safety and EMC testing and firmware programming workflows for embedded systems.

Proficiency with data acquisition automation platforms (LabVIEW PLC or custom test systems) and firmware flashing / configuration processes during production.

Working knowledge of CAD tools (SolidWorks) for fixture and tooling design as well as statistical analysis tools (Minitab JMP) for process optimization.

Knowledge of firmware update validation system calibration automation or traceability tools in regulated environments.

$115600 - $190400 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage : 10%

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 contractors legal duty to furnish information.

Required Experience :

Staff IC

Key Skills

Laboratory Experience,Vendor Management,Design Controls,C / C++,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 115600 - 190400