Shire Veteran Jobs

Senior Design Assurance Engineer

Newark, DE, United States

Job Summary:

Ensures safety and effectiveness are designed into and maintained in medical devices, through expertise in design control, risk management, quality systems and change management.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

Essential Duties and Responsibilities:

• Medical Device Quality Assurance: Provide comprehensive support to ensure the quality, compliance, and safety of medical devices throughout their lifecycle, from product development to post-market follow-up. Significantly contribute to assessing product performance, accuracy, and clinical efficacy.

• Administrative Responsibilities: Attend all relevant meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc.), and efficiently manage email and other communication platforms.

• Sustaining Activities: Facilitate design controls for manufacturing and design changes of marketed medical devices, implement manufacturability improvements, and lead or participate in business continuity projects (e.g., internalizations, supplier changes, value improvement projects), while maintaining quality, compliance, and safety.

• Quality Assurance Activities: Continuously update learning assignments related to internal procedures, support internal and external audits, manage NCEs, CAPAs, SSEs, QPLs, and other quality metrics, and assist in post-market surveillance complaint investigations.

• Risk Management: Implement and maintain risk management processes throughout the device product lifecycle.

• Product and Design Requirements: Ensure that product and design requirements are properly established, qualified, and met.

• Change Request Assessments: Evaluate product change requests for their impact on design, prioritizing compliance to maximize quality and customer safety.

• Design Assurance Support: Support all activities where Design Assurance is Responsible, Accountable, and Consulted during product development or transfers (including acquisitions), validation, verification, and clinical preparation as applicable.

• Collaboration: Work within multifunctional teams to develop strategies that challenge medical device design and performance, creating objective evidence for quality and safety compliance.

• Test Method Development: Participate in developing and validating test methods, and maintain accurate records of testing strategies and outcomes.

• Health Risk Assessments: Conduct health risk assessments for on-market products, ensuring efficient and effective analysis, including problem definition and impact evaluation.

• Risk Assessments: Execute risk assessments to support both on-market devices and new product development programs.

Qualifications:

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

• 3-5 years of experience

• 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:

• Drive action using Deming Cycle (PDCA) principles

• Knowledge of verification, validation, and requirements analysis for regulated products

• Experience in project teams and leadership roles for timely task completion

• Assess and communicate compliance in product and project documentation

• Strong written, verbal, and technical communication skills; fluent in English

• Strong presentation skills

• Knowledge of test method validation, root cause analysis, statistical methods, and design of experiments

• Skills in communication, collaboration, responsibility, organization, problem solving, strategic thinking, and adaptability

• Bilingual is a plus

• ASQ Certified Quality Engineer and Six Sigma Certification are 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 $94,800 to $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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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