Staff R&D Engineer- NPD (Onsite Irvine, CA)

Work Flexibility: Onsite

What You Will Do

• Lead the design development and optimization of mechanical medical device components assemblies and/or subsystems from concept through commercialization.

• Translate user customer and clinical needs into design inputs engineering specifications and system-level product requirements.

• Develop and execute design verification and validation strategies including prototyping testing and analysis to ensure product performance and reliability.

• Apply sound engineering judgment to identify troubleshoot and resolve complex product design challenges.

• Create and maintain engineering documentation including CAD models drawings GD&T specifications test protocols test reports and/or Design History File (DHF) deliverables.

• Collaborate cross-functionally with Quality Manufacturing Regulatory Clinical Marketing and Project Management teams to drive successful product development and launch activities.

• Support Voice of Customer (VOC) initiatives and utilize clinical and market insights to develop innovative product solutions.

• Ensure compliance with medical device regulations industry standards design controls risk management processes and quality system requirements.

What You Need (Required Qualifications)

• Bachelors degree in Mechanical Engineering Biomedical Engineering or a related engineering discipline.

• 4 years of relevant engineering experience.

• Experience developing mechanical and/or electro-mechanical products in a regulated industry preferably medical devices.

• Strong expertise in product design Design for Manufacturability (DFM) materials selection manufacturing processes and mechanical problem-solving.

• Proficiency creating engineering drawings (GD&T experience preferred) and 3D CAD models (SolidWorks preferred).

• Experience with prototyping verification and validation testing data analysis and root-cause investigation.

• Working knowledge of Design Controls Risk Management and Quality Management Systems within a regulated product development environment.

• Proficiency with Microsoft Office Suite (e.g. Word Excel PowerPoint)

Preferred Qualifications

• Medical device manufacturing experience.

• Experience with machine shop operations injection molding and additive manufacturing (3D printing).

• Experience supporting FDA submissions including 510(k) and/or PMA programs.

• Familiarity with applicable medical device regulations and industry standards.

• Experience with MS Project and Minitab.

$102700 - $171100 USD Annual

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.