Senior Engineer - Product Engineering

Stryker Corporation; Phoenix (AZ); Hybrid; USD 78,000 - 130,000; Full time

Benefits offered by this job

Travel 10%

Job summary

Stryker Corporation in Phoenix, AZ, is seeking a Senior Engineer in Product Engineering to lead sustaining projects for medical devices. You will investigate issues, implement design and process improvements, and work with Quality, Regulatory Affairs, Operations, and other teams to ensure product performance and compliance.

The role requires a Bachelor's in a engineering field and at least 2 years in a regulated setting, with knowledge of design controls, CAPA, and regulatory submissions.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related field.
• Minimum 2 years of engineering experience in a regulated industry.
• Experience with product investigations, design changes, validation activities, or quality improvements.
• Knowledge of medical device regulations and regulatory submissions.

Responsibilities

• Lead and support sustaining engineering projects for released medical devices, including design changes, line extensions, and product improvements.
• Investigate product, process, and packaging issues, identify root causes, and implement corrective and preventive actions.
• Coordinate design control, risk management, validation, and regulatory activities for product changes.
• Collaborate with cross-functional teams to support business objectives and drive quality and reliability.
• Apply statistical analysis to evaluate performance data and support technical decisions.

Skills

Statistical analysis

Regulated industry

Root cause analysis

Cross-functional collaboration

Education

Bachelor's in Mechanical Engineering

Tools

CAPA

Design controls

Validation protocols

Job description

## Senior Engineer - Product EngineeringApply: Phoenix, Arizona: Full time: Posted 2 Days Ago: R573087Work Flexibility: Hybrid**Senior Engineer - Product Engineering***Phoenix, AZ*This position focuses on sustaining engineering activities that enhance product performance, quality, manufacturability, and regulatory compliance. Working across cross-functional teams, you will investigate product issues, implement design and process improvements, and help ensure products continue to meet customer and business needs.**Work Flexibility:** Hybrid: candidates must reside within commuting distance of Phoenix, AZ and be able to work onsite several days per week.**What You Will Do*** Lead and support sustaining engineering projects for released medical devices, including design changes, line extensions, and product improvements.* Investigate product, process, and packaging issues, identify root causes, and implement corrective and preventive actions.* Partner with Quality teams to evaluate customer complaints and resolve product performance concerns.* Coordinate design control, risk management, validation, and regulatory activities associated with product changes.* Represent Research & Development on continuous improvement initiatives that enhance product quality, reliability, and operational efficiency.* Conduct engineering studies, testing, and validation activities to support design changes and process improvements.* Collaborate with Operations, Manufacturing, Quality, Regulatory Affairs, Marketing, Sales, suppliers, and customers to support business objectives.* Apply statistical analysis and engineering principles to evaluate performance data and support technical decision-making.**What You Will Need****Required Qualifications*** Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field.* Minimum 2 years of engineering experience in a regulated industry.* Experience supporting product investigations, design changes, validation activities, or quality improvement initiatives.**Preferred Qualifications*** Knowledge of medical device regulations, including design control requirements and regulatory submissions.* Experience supporting complaint investigations, corrective and preventive actions (CAPA), or post-market product support.* Experience with statistical analysis and data-driven problem solving.* $77,700 - $129,500 USD AnnualTravel 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 contractor’s legal duty to furnish information.