Andover MA: Sr Design Assurance Engineer (232086)

Engineering Services
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Responsibilities:

• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements

• Review, and approve design control deliverables such as requirements, specifications, validation protocols and reports to ensure compliance to customer and regulatory requirements.

• Review and approve human factors documentation such as use specifications, task analysis, formative and summative studies protocols and reports.

• Support Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR).

• Support safety assurance case creation in compliance with the regulatory requirements.

• Provides guidance to cross-functional development team(s) in approach to design control documentation.

• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps

• Support design test and inspection method development, and lead method validation activities

• Responsible for establishing, communicating, and mitigating risk throughout the product development process

• Participate in design reviews

• Performs other related duties and responsibilities, on occasion, as assigned

 

Experience and Education:

• B.S. degree, in a scientific, technical, or engineering discipline.

• 5+ Years of experience in design controls and risk management

• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and ISO 14971

• Must possess excellent oral and written communication skills, and the ability to communicate appropriately with cross functional teams

• Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter

• Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.

• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations.

Andover MA: Sr Design Assurance Engineer (232086)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
Massachusetts
(Remote)

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