Job Description

Why Hologic:

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

What to expect:

• Provide design assurance support for new product development and on market medical devices. This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
• Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. Test method validation would be an element of assuring verification/validation is acceptable.
• Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed..
• Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
• Assess change requests of product for impact to design, determine supporting information required for implementation of changes.

What we expect:

• Responsible for independently assessing the health risk of various situations, including deviations, nonconformances, design verification failures, or proposed product changes. Must demonstrate efficient and effective analysis of situation, including problem definition and connection with associated post-market processes.
• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
• Experienced with ISO 14971, Risk Management
• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.

Education & Experience:

• Technical Bachelor Degree, Electrical or Software Engineering preferred
• 2-5 years’ experience preferably in medical device industry
• Experience with capital medical devices with complex electromechanical systems and software preferred

The annualized base salary range for this role is $97,000 to $152,000 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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Must follow all applicable FDA regulations and ISO requirements.

Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)