Senior Product Engineer | Cambridge
We're working with Hologic on this exciting opportunity.
This role offers the chance to make a tangible impact on cancer care by redefining cancer treatment with innovative medical solutions. You will play a critical role in supporting released products and managing the transition of new innovations, ensuring the highest quality standards and optimal outcomes for patients.
Key Responsibilities
* Act as technical lead for sustaining activities on current surgical guidance and implantable products.
* Drive improvements to design for manufacturability, serviceability, and cost-efficiency.
* Support change control processes and documentation in alignment with quality system requirements.
* Ensure compliance with all applicable medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and MDR.
* Participate in supplier audits, validations, and technical reviews.
What You'll Need
* A technical or scientific background in engineering.
* Experience in high-tech engineering to exacting standards, ideally within medical device industry.
* Understanding of quality and regulatory requirements, including ISO 13485, MDSAP, MDD/MDR, and 21 CFR.
* Experience working with international manufacturing or supply partners.
* Skilled in leading process & continuous improvement projects, ensuring successful implementation within set timelines.
What's On Offer
* Innovate with Purpose: Work at the forefront of life-changing medical technology.
* Collaborative Culture: Join a friendly, supportive team where your contributions matter.
* Personal Growth: Expand your skills in a fast-growing, global company.
Apply via Haystack today!