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Connexion Systems + Engineering
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Emily Donahue
Senior Design Assurance Engineer
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Senior Design Assurance Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Job Summary
Provide design assurance support for new product development and on market medical devices. This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
Essential Duties
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
Qualifications
Preferred Skills:
Physical Demands
A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Title: Senior Design Assurance Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Approved until 11/28/2025
- Pay rate: $45-$70/hr.
- Job Location: Marlborough, MA
- Schedule: M-F 1st shift, flexible hours
- Job#: bh17700
Job Summary
Provide design assurance support for new product development and on market medical devices. This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
Essential Duties
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
- Participating independently in a new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm input requirements are met. Test method validation would be an element of assuring verification/validation is acceptable.
- Participate independently in doing thorough reviews/audit of Design History File (DHF) documentation for capital and disposable medical devices, including design plans, design inputs/outputs, verification/validation activities, design changes, and design transfer documentation.
- Participate independently on thorough reviews/audit Requirements Trace Matrix and assuring the trace matrix is accurate and meeting design control requirements for medical devices.
- Participate independently on sustaining product projects, assuring projects is clearly defined and stay on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.
- Work collaboratively with R&D to coordinate the design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
- Responsible for independently coordinating the Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
- Assess change requests of product for impact to design, determine supporting information required for implementation of changes.
Qualifications
- Technical bachelor’s degree
- 2-5 years’ experience preferably in the medical device industry
- Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
- Experienced with ISO 14971, Risk Management
- Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
- Working knowledge of verification and validation requirements for a regulated product
- Working knowledge of requirements analysis, including development of testable and measurable specifications
- Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
- Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment
Preferred Skills:
- Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment
Physical Demands
A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions
- Sit; use hands to finger, handle or feel objects, tools, or controls.
- Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Meet Your Recruiter
Emily Donahue
Regional Recruiting Manager
- Directs the recruitment efforts for both the Quincy, MA and Providence, RI branches.
- Manages a distributed team of recruiting leads, individual contributor recruiters and account managers.
- Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region.
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Ready to take your career to the next level? Explore our job opportunities in the vibrant area surrounding Marlborough, Massachusetts! Located in the heart of New England, Marlborough offers a perfect blend of rich history, stunning landscapes, and endless growth opportunities. Whether you're drawn to the serene beauty of Upton State Forest or the cultural delights of the Worcester Art Museum, this region has something for everyone. Indulge in delectable clam chowder at a local seafood joint or catch a game at Fenway Park to experience the passion of Boston sports fans firsthand. With renowned theaters like Hanover Theatre and exciting professional sports teams like the New England Patriots and Boston Celtics, Marlborough, MA, is not just a place to work – it's a place to thrive. Explore our job listings today and kickstart your exciting career journey in this enchanting region!
