Work Flexibility: Hybrid
Senior Design Quality Engineer
Redmond WA
As a Senior Design Quality Engineer youll play a critical role in ensuring our innovative products meet the highest standards of safety and performance. This is your opportunity to influence product development from concept through launch and beyond driving quality that improves patient outcomes worldwide.
Work Flexibility:
Hybrid must reside within a commutable distance to Redmond WA and work onsite several times per week.
What You Will Do
- Partner with cross-functional teams to integrate quality requirements into new product development processes.
- Lead product safety risk management activities including hazard analysis DFMEA and risk assessments for distributed products.
- Develop and approve validation strategies plans protocols and reports to ensure compliance with design validation policies.
- Optimize test plans methods and sampling strategies to meet regulatory and quality standards.
- Establish and monitor field performance metrics post-launch; analyze trends and recommend improvements.
- Drive timely resolution of quality issues serving as a key contributor in CAPA investigations and risk management activities.
- Participate in internal and external audits providing expertise on design controls and product development processes.
- Lead initiatives to improve quality systems and processes across the organization.
What You Will Need
Required Qualifications
- Bachelors degree in Engineering Science or a related field.
- 2 years of experience in a highly regulated environment (quality manufacturing or engineering).
- Demonstrated experience contributing to a design development project
Preferred Qualifications
- Bachelors degree in Biomedical Engineering
- Prior experience with electromechanical design and embedded software in product development.
- Knowledge of medical device industry regulations and standards.
- Familiarity with quality tools such as root cause analysis sampling plans and validation testing.
- Understanding of good design practices specification development and industry standards.
$89400 - $148900 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:
Senior IC
Work Flexibility: HybridSenior Design Quality Engineer Redmond WAAs a Senior Design Quality Engineer youll play a critical role in ensuring our innovative products meet the highest standards of safety and performance. This is your opportunity to influence product development from concept through lau...
Work Flexibility: Hybrid
Senior Design Quality Engineer
Redmond WA
As a Senior Design Quality Engineer youll play a critical role in ensuring our innovative products meet the highest standards of safety and performance. This is your opportunity to influence product development from concept through launch and beyond driving quality that improves patient outcomes worldwide.
Work Flexibility:
Hybrid must reside within a commutable distance to Redmond WA and work onsite several times per week.
What You Will Do
- Partner with cross-functional teams to integrate quality requirements into new product development processes.
- Lead product safety risk management activities including hazard analysis DFMEA and risk assessments for distributed products.
- Develop and approve validation strategies plans protocols and reports to ensure compliance with design validation policies.
- Optimize test plans methods and sampling strategies to meet regulatory and quality standards.
- Establish and monitor field performance metrics post-launch; analyze trends and recommend improvements.
- Drive timely resolution of quality issues serving as a key contributor in CAPA investigations and risk management activities.
- Participate in internal and external audits providing expertise on design controls and product development processes.
- Lead initiatives to improve quality systems and processes across the organization.
What You Will Need
Required Qualifications
- Bachelors degree in Engineering Science or a related field.
- 2 years of experience in a highly regulated environment (quality manufacturing or engineering).
- Demonstrated experience contributing to a design development project
Preferred Qualifications
- Bachelors degree in Biomedical Engineering
- Prior experience with electromechanical design and embedded software in product development.
- Knowledge of medical device industry regulations and standards.
- Familiarity with quality tools such as root cause analysis sampling plans and validation testing.
- Understanding of good design practices specification development and industry standards.
$89400 - $148900 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:
Senior IC
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