JOB SUMMARY:
Identifies, investigates, plans, and conducts activities to improve or ensure quality through design and manufacturing of medical devices and components. Cross-functionally collaborates with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components.
ESSENTIAL/PRIMARY DUTIES:
- Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).
- Assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.
- Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.
- Identifies testing and validation opportunities, contributes to product and process improvements.
- Works on moderately complex projects, generates alternatives, and conducts testing.
- Applies new tools and identifies opportunities for improvements using six sigma methods.
- Conducts the design and process failure mode and effects analysis (FMEA) process.
- Participates in Design Control Process (including design input, design output, reviews, qualifications, validations, etc.).
- Identifies and communicates risks, participates in issue resolution, mentors junior engineers.
- Applies advanced engineering methods and tools to solve engineering problems.
SECONDARY DUTIES:
- Provides leadership, coaching, and/or mentoring to the co-op group and level I engineers.
- Supports internal and external QMS audits and/or investigations.
- Understands engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.
- Follows industry standards and regulations for quality, safety, and performance.
EDUCATION and/or EXPERIENCE:
Bachelor's degree in engineering or related field and 2+ years of relevant experience, or similar combination of both. Six Sigma Greenbelt certification is preferred.
COMPETENCY and/or SKILL:
- Fully understand basic engineering tools and methods
- Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
- Strong written and verbal communication skills
- Ability to contribute ideas for process changes and improvements
- Ability to define and analyze complex problems
- Ability to generate alternatives and take reasonable risks to solve technical problems
SUPERVISORY RESPONSIBILITIES:
- Provides leadership, coaching, and/or mentoring to level I engineers and co-op's.