"Alerted.org

Job Title: Senior / Principal Design Assurance Engineer

Job Type: Direct Hire

Position Overview: We are seeking an experienced Senior Design Assurance Engineer in the Minneapolis area. This role offers an exciting opportunity to contribute to the development and validation of innovative medical devices in a collaborative, fast-paced environment. As a key member of the design assurance team, you will play a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products.

Key Responsibilities:

+ Lead and support design assurance activities throughout the product development lifecycle, ensuring compliance with regulatory standards (FDA, ISO, etc.).

+ Review and approve design documentation, including design control deliverables (Design Inputs, Design Outputs, Design Verification/Validation).

+ Provide guidance and support to cross-functional teams in the implementation of risk management processes (FMEA, Hazard Analysis, Risk Assessment).

+ Conduct and document risk management assessments and collaborate with product development teams to mitigate identified risks.

+ Support the creation and execution of design validation and verification protocols, ensuring adherence to quality and regulatory standards.

+ Participate in design reviews and provide expert feedback on product designs, including design transfer activities and design history file maintenance.

+ Work closely with quality assurance, regulatory, and manufacturing teams to ensure seamless transitions between design and production stages.

+ Contribute to the preparation for regulatory inspections, audits, and external assessments.

+ Ensure that design control documentation, test protocols, and reports meet FDA and ISO 13485 guidelines.

Qualifications:

+ Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field (or equivalent experience).

+ 5+ years of experience in medical device design assurance, with a deep understanding of FDA and ISO 13485 regulatory requirements.

+ Proven experience working with design control processes, including design verification/validation, risk management, and design documentation.

+ Experience with regulatory submissions, audits, and inspections.

+ Strong understanding of risk management techniques (e.g., FMEA, Fault Tree Analysis).

+ Excellent communication and interpersonal skills, with the ability to work cross-functionally with diverse teams.

+ Ability to manage multiple projects in a fast-paced, dynamic environment.

+ Experience with quality management systems (QMS) and maintaining a design history file (DHF) is highly preferred.

+ Strong problem-solving skills, attention to detail, and the ability to anticipate and mitigate potential risks in the development process.

Preferred Qualifications:

+ Experience with medical device combination products or active implantable devices.

+ Six Sigma or other process improvement certifications are a plus.

Compensation:

+ $115k-$150k

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