Hologic Lead Design Assurance Engineer in Marlborough, Massachusetts
Lead Design Assurance Engineer
Marlborough, MA, United States
Our Design Assurance team is looking for an experienced Lead Design Assurance Engineer to join our Surgical Solutions division. We have so many innovative products in the development pipeline we want you to join and lead us to technical compliance and commercial success!
So what does this role involve? You will:
Leadthe design assurance team through improving procedures and processes acting as a mentor and coach.
Facilitatethe application of design controls whilst supporting product development, manufacturing related design changes, regulatory compliance, improvements for manufacturability and evaluate cost reduction efforts.
Collaboratewith your wider colleagues from regulatory, R&D and engineers.
Sustainproduct projects ensuring the project is clearly defined, on task, verified, validated and risk managed.
Coordinatethe Health Risk Assessment team when needed for evaluations of on-market product. You will be able to analyze, define problems that may arise and measure impact.
To join us here in our mission to become global champions of women’s health, we do have some minimum expectations you will need to have for this role. These include:
Education: Technical Bachelors Degree
Skills & Experience:
Experience with FDA Quality System Regulations including Design Control requirements, ISO 13485and Medical Device Directive
Experience with ISO 14970 – Risk Management
You should be familiar with usability, reliability, electrical safety, software, sterilization, packaging and biocompatibility standards and requirements
Knowledge of verification and validation requirements for regulated products
Leadership exposure in projects
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. 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.
We offer a competitive salary, benefits and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
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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