Job Description
We are seeking a Senior Design Quality Engineer to join our growing team. This role is responsible for ensuring quality and compliance throughout the product development lifecycle, from concept through commercialization. The ideal candidate will bring deep expertise in design controls, risk management, and quality systems within the medical device industry.
New Product Development Team Member
- Responsible for R&D Quality Engineering activities
- Support new initiatives on R&D Projects
- Maintain Design Control Phase Gates and deliverables
- Participate in design reviews
- Conduct Risk Analyses with Design Team
- Support Design for Manufacturability, Reliability, Usability, V&V activities
- reviewing & writing technical reports, validations
- Support Supplier Qualification activities
Sustaining Quality Support
- Support QMS activities including internal audits, CAPAs, and complaint investigations
- Help maintain a compliant and effective QMS
- Maintain and update Risk Management Files
Quality Operations Support
- Assist in QMS activities
Qualification Requirements:
- Must be able to read and communicate in English
- High attention to detail
- Exceptional communication skills
- Problem-Solving/Critical Thinking skills
- Basic reading and understanding of engineering drawings
- Dependable, reliable
- Proficiency with Microsoft Office products (Word, Excel, & Office)
- Data Analytics capabilities in Excel, Minitab for Post Market data and statistical analysis for sample sizes
- Ability to work in a team environment and independently with minimal supervision
Preferred Qualifications/Experience:
- 5+ years of professional experience in Medical Device
- Education: Engineering/Technical Degree Required, Mechanical Preferred
- Experience with Greenlight Guru QMS platform
- Familiarity with Lean / Six Sigma methodologies and Design of Experiments (DOE)
- Prior involvement in electromechanical, mechanical, and sterile medical devices
- Class III implantable device experience
- Reusable Instrument experience
- Proficient with Design Controls and related Regulations/Standards (ISO-13485, 21CFR820, ISO-14971, ISO-62366, EU/MDR)
