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Design Assurance Engineer 1

Marlborough, MA, United States

Job Summary:

Provide design assurance support for on market medical devices. This role will be responsible, with supervision, 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.

Works on problems of limited scope. Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Normally receives detailed instructions on all work.

What To Expect:

• Participate 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. This role may also include support of new product development.

• Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.

• Responsible for coordinating Health Risk Assessment team with support of lead/manager when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.

• Assess change requests of product for impact to design, determine supporting information required for implementation of changes.

What We Expect:

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)

• 0-2 years’ experience preferably in medical device industry

• Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Regulation

• Familiarity with ISO 14971, Risk Management

• Ability to effectively work on project teams

• Strong written, verbal and technical writing communication skills

• Ability to effectively prioritize and coordinate project activities

• Preferred:

• Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment

• Familiarity with verification and validation requirements for a regulated product

• Familiarity with requirements analysis, including development of testable and measurable specifications

• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.

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 $62,900 to $98,400 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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