Senior Design Assurance Engineer

March 29, 2023

Position Summary:

This position is responsible for Design Assurance Engineering deliverables relating to Product Development, Reliability, Risk Management, Quality, and New Product Introduction (NPI).

Essential Duties and Responsibilities:

• Participates in Product Development and Manufacturing teams
• Develops and maintains product requirements and design specifications documentation
• Develops verification and validation protocols and writes reports
• Supports design verification and validation testing including biocompatibility, packaging, shelf life, and sterilization activities
• Designs and develops test fixtures and measurement systems for use in V&V and manufacturing
• Completes Test Method Validations
• Supports IQ, OQ, and PQ Process Validations
• Prepares inspection plans and control plans
• Participates in Material Review Board activities and dispositions of nonconforming inventory
• Prepares document changes for release and supports the management of controlled documentation
• Maintains detailed records including Lot History Records and Device History Records
• Supports audits of the QMS by customers and regulatory bodies
• Leeds and/or supports Risk Management activities
• Supports the Supplier Management Process including conducting supplier audits
• Supports the CAPA process and leads some CAPA efforts

Required Education, Experience, Skills, and Knowledge:

• Minimum 6 years experience in a Quality, Manufacturing, or Product Development Engineering role
• Medical Device experience required
• Product development experience required
• Bachelor’s Degree in Engineering or Technical Field
• Familiarity with statistical methods and sampling plans
• Familiarity with 21 CFR 820 and ISO 13485
• Knowledge of statistical methods (t-tests, ANOVA, Gage R&R, DOE, Process Capability, Reliability)
• Depth of knowledge in one or more product/technology areas
• Excellent aptitude and confidence in customer-facing communications
• Detail-oriented, organized, and diligent in record keeping and Good Documentation Practices (GDP)
• Willing to learn and grow within the organization

Skills Proficiency:

• Demonstrates a strong work ethic, thrives in a collaborative environment, and offers creative and innovative solutions to challenging project deliverables and tight timelines 
• Demonstrates a willingness to learn and grow within the organization 
• Demonstrates strong aptitude and confidence in customer-facing communications 
• Demonstrates a detail-oriented, organized, and diligent approach to record-keeping and Good Documentation Practices (GDP) 

Salary Range:

$76,000 to $104,000 (25th percentile/90th percentile, PayScale data); Bonus eligible depending on achieving company performance targets. 

Benefits:

This position will be eligible to enroll in benefits including health, dental, and vision programs as well as AD&D and Long-Term Disability Insurance, 401(k).  The position will accrue 15 PTO days per year and 1 additional day for each year of service (up to 25 days).   

Apply to: humanresources@meddux.com