Sr. Design Assurance Engineer - Stop Ship

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Sr. Design Assurance Engineer - Stop Ship

Marlborough, MA, United States

Newark, DE, United States

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The Senior Design Engineer - Stop Ships ensures the safety, effectiveness, and compliance of medical devices by applying expertise in design controls, risk management, quality systems, and change management. This experienced professional leads the assessment and resolution of product quality and safety issues, including Stop Ship activities, using sound technical judgment and analytical problem-solving skills. Working independently with minimal supervision, they evaluate complex situations, drive effective solutions, and collaborate with cross-functional teams and senior stakeholders to maintain product quality, regulatory compliance, and patient safety throughout the product lifecycle.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Maintains and employs extensive integrated knowledge of assigned products to provide support assuring Medical Device Quality, Compliance and Safety along life cycle from product development to market and post-market follow-up. Significant contributor in activities to assess product performance accuracy and clinical efficacy.
• Administrative Responsibilities include attending all meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc.), reviewing and responding to emails and other messaging platforms.
• Responsible for sustaining activities of marketed Medical Devices include facilitating the application of design controls for manufacturing and design changes, implementing improvements for manufacturability, participating or leading business continuity projects (i.e., internalizations, supplier changes and value improvement projects), all while assuring quality, compliance, and safety.
• Responsible for Quality Activities include constant refreshing of learning assignments of internal procedures, supporting internal and external audits, supporting NCEs, CAPAs, SSEs, QPLs and other quality figures, and supporting complaint investigation for Post Market Surveillance.
• Implementation and maintenance of Risk Management throughout the device product life cycle.
• Ensure product and design requirements are properly established, qualified, and met.
• Assess change requests of products for impact to design, prioritizing compliance to maximize quality and customer safety.
• Support all activities that Design Assurance is Responsible, Accountable, and Consulted for during product development or product transfers (acquisitions) including validation, verification, and clinical preparation where applicable.
• Collaborate in multifunctional teams to develop strategies that challenge the medical device design and performance and create objective evidence for quality and safety compliance.
• Participate in Test Method Development and Validation.
• Maintain accurate records of testing strategies and outcomes.
• Conduct Health Risk Assessments when needed for evaluating an on-market product, demonstrating efficient and effective analysis of the situation, including problem definition and impact.
• Execute Risk Assessments in support of both on-market devices and new product development programs.

Qualifications:

Education

• Bachelor's Degree (Engineering, Biomedical or related field preferred), May have Master's Degree, May have PhD

Experience

• 5-8 Years of Experience with a Bachelor's Degree
• 2-5 Years of Experience with a Bachelor's Degree in a Technical Field
• 1-3 Years of Experience with a Master's Degree
• 0-1 Years of Experience with a PhD
• Experienced with FDA-Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019, Risk Management, ,Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive, Regulation (EU) 2017/745 (MDR) European Union Medical Device Regulation
• Prior experience in medical device or other highly regulated industry
• Experienced with Good Laboratory Practices
• Experienced with Usability, Reliability, Electrical Safety and Software standards and regulations.

Skills

• Ability to drive action in accordance with Deming Cycle (PDCA) Principles

• 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.

• Strong written, verbal and technical writing communication skills. Fluent English (written and verbal).

• Strong presentation skills

• Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments

• Communication/Active Listening, Collaboration/Team Player, Responsibility/Accountability and Reliability, Organization/Planning/Time Management, Problem Solving/Creativity, Strategic, Analytic/Focus/Critical Thinking, Flexibility and Adaptability

• Bilingual is beneficial.

• ASQ Certified Quality Engineer is desirable.

• Six Sigma Certification is desirable.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is 97,600 - $125,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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