Sr. Development Quality Engineer

Mindlance; Pleasanton (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative staffing firm is seeking a Sr. Development Quality Engineer to provide design quality expertise to product development teams. This role involves leading risk management activities, supporting test method development, and ensuring compliance with FDA and other regulatory requirements. The ideal candidate will have extensive experience in medical devices and a strong collaborative spirit to maintain positive communication across teams. Join this dynamic environment where your contributions will directly impact patient safety and organizational success.

Qualifications

• 5+ years in R&D, Process/Manufacturing Engineering, and/or Quality.
• Experience in medical devices and related regulations/standards.

Responsibilities

• Lead on-time completion of Design Control deliverables.
• Support Design Verification and Validation planning & execution.

Skills

Risk Management

Test Method Development

Quality Assurance

Regulatory Compliance

Collaboration

Education

Bachelor’s degree in Engineering

Advanced Degree in Engineering

Tools

DOORS

JIRA

Job description

The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.

Responsibilities

1. Lead and/or support the on-time completion of Design Control deliverables.
2. Support the establishment of objective, measurable, and verifiable product requirements.
3. Support Design Verification and Validation planning & execution, including cross-functional investigation & resolution activities.
4. Lead Risk Management activities from product concept through commercialization.
5. Support test method development and lead test method validation activities.
6. Support manufacturing process development & qualification for new products and design changes.
7. Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications.
8. Support biocompatibility and sterilization qualifications.
9. Support audits and quality system improvement activities.
10. Support company initiatives aligned with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
11. Ensure compliance with client, U.S. FDA, EUMDR, and other applicable requirements.
12. Maintain positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and suppliers.

Basic Qualifications

• Bachelor’s degree in Engineering or a Technical Field.
• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality, with at least 2 years supporting product development.
• Experience in medical devices and related regulations/standards.
• Experience in test method development and validation.
• Experience in preparing risk assessments, FMEA, and other risk management documents.

Preferred Qualifications

• Advanced Degree in Engineering/Technical Field.
• Experience with active implantable medical devices.
• Knowledge of requirements management tools (e.g., DOORS) and problem reporting systems (e.g., JIRA).
• Working knowledge of statistics and its application to verification and validation.

EEO Statement

Mindlance is an Equal Opportunity Employer and does not discriminate based on minority, gender, disability, religion, LGBTQI, age, or veteran status.

About the Company

Mindlance is one of the largest diversity-owned staffing firms in the US. As a recruitment-centric talent acquisition company, Mindlance provides staffing services across various sectors including Technology, Engineering, Digital/Creative/Marketing, Clinical Research, Scientific, Finance, and Payroll Management to Global 1000 companies across the US, Canada, and India.