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. 


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: 

    Meddux Development Corporation is an equal opportunity employer and considers all applicants for employment without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, gender identity, transgender status, pregnancy or a condition related to pregnancy, age (as defined by law), disability, military or veteran status, genetic information, or based on any individual’s status in any group or class protected by applicable federal, state, or local law.  Meddux provides reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law.  If you require an accommodation in the application process, please contact Human Resources.