Project Engineer 4

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:

• Provide extensive product knowledge to support Medical Device Quality, Compliance, and Safety throughout the product life cycle.
• Attend various meetings and manage administrative tasks.
• Facilitate design controls for manufacturing changes, implement manufacturability improvements, and lead business continuity projects.
• Engage in quality activities, including audits, CAPAs, complaint investigations, and risk management.
• Ensure product and design requirements meet quality and safety standards.
• Assess product change requests for compliance and customer safety.
• Support Design Assurance activities during product development and transfers.
• Collaborate with multifunctional teams to ensure quality and safety compliance.
• Participate in Test Method Development and Validation, maintaining accurate records.
• Conduct Health and Risk Assessments for on-market products and new developments.

Experience:

• 5-8 Years of Experience with a Bachelor's Degree (Engineering, Biomedical or related field preferred)
• 20 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 $130,950 to $163,250 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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