Senior Engineer, Design Quality at Stryker

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DeviceIndustries

Requirements

Bachelor’s degree in science, engineering or related discipline
2+ years’ related experience required
Medical device industry experience required
Familiarity with New Product Development (NPD) processes and/or involvement in cross-functional activities supporting product development and commercialization
Preferred:
MS, CQE, or CRE preferred
Six Sigma Green or Black belts are preferred
Experience with the medical device development lifecycle, including risk management and design/process verification and validation
Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts
Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations
Proven project management and cross-functional collaboration skills
Excellent communication, problem-solving, and analytical abilities

Responsibilities

Develop quality documentation to support new product development and regulatory submissions
Maintain and improve quality systems by identifying and correcting procedural deficiencies
Support risk management activities and contribute to risk/benefit analyses
Collaborate on product and process design activities in cross-functional teams
Help define and validate design verification and validation (V&V) test requirements and methods
Present product risks during design reviews and ensure mitigation through development
Support manufacturing process development and product design transfer to internal/external sites
Apply statistical analysis and problem-solving techniques to define acceptance criteria and resolve quality issues
Review and approve inspection plans, routers, and product drawings
Evaluate predicate devices and define critical quality attributes through risk analysis
Contribute to final V&V reports with statistically valid conclusions and graphical summaries
Support early market feedback collection and resolution of initial product concerns

Skills

Key technologies and capabilities for this role

Design QualityRisk ManagementQuality SystemsDesign VerificationDesign ValidationStatistical AnalysisProblem-SolvingMedical DeviceNew Product DevelopmentNPDSix SigmaCQECRE

Questions & Answers

Common questions about this position

What is the salary range for the Senior Engineer, Design Quality position?

The salary range is $88,800 - $142,300 plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Is this role remote or onsite?

The position is onsite in Irvine, California, with no travel required.

What skills and experience are required for this role?

A Bachelor’s degree in science, engineering or related discipline, 2+ years’ related experience, and medical device industry experience are required. Familiarity with New Product Development (NPD) processes and cross-functional activities is also needed.

What preferred qualifications will make me stand out?

Preferred qualifications include an MS, CQE, or CRE certification, Six Sigma Green or Black Belt, experience with the medical device development lifecycle, proficiency in quality tools like FMEA and GD&T, data analysis tools like Minitab, and strong project management and communication skills.

Does this role involve teamwork?

Yes, the role involves collaborating on product and process design activities in cross-functional teams and partnering with Engineering and Advanced Operations.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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