- Fresenius Medical Center (Lawrence, MA)
- …detailing, geometric tolerance analysis, and documentation is preferred + Strong understanding of medical device development processes + Able to communicate ... and/or testing of complex electro-mechanical products preferred + Prior medical device experience strongly preferred EO/AA Employer:… more
- Fresenius Medical Center (Lawrence, MA)
- …remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ... compliance. . Reviews and approves design control deliverables along the product development process as well as design changes . Partners with and/or guide… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …expertise in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) ... Engineer to join our growing team and lead the development and strategy for our Digital Medicine Platform's service...CI/CD for AWS serverless deployments + PHI/PII and/or Med device or other device -related experience + Demonstrated… more
- Amgen (Cambridge, MA)
- …products and device regulatory requirements, medical device development and design controls, and knowledge of process controls. + Excellent ... to create models capturing the inherent variability in the process and device dimensions. + Skilled in...towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Responsible for development , coordination, preparation and maintenance of US medical device submissions such as Pre-Submissions, 510(k)s, PMAs, IDEs and ... + Where designated, responsible for development , coordination, preparation and maintenance of medical device submissions for Canadian Class 2, 3 or 4 … more
- ZOLL Medical Corporation (Chelmsford, MA)
- …compliance philosophies and strategy: + Needs assessment + Risk Assessment + Policy and process development at both the corporate and division levels + Training ... leading a team that facilitates this approach through the development and implementation of tailored training, working with the...more years in life science organizations, ideally in the medical device industry. Knowledge, Skills and Abilities… more
- Takeda Pharmaceuticals (Boston, MA)
- …of 8 years regulatory and/or related experience. + Expert knowledge of device development , registration and maintenance regulations with experience in ... and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development and… more
- Amgen (Boston, MA)
- …+ Bachelor's Degree and 3 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience OR + Associate degree ... and 6 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience OR + High school diploma/GED and 8 years… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …years of experience as an engineer developing products, preferably in the medical device industry required + Project Management Professional (PMP) certification ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide...the system level. + Experience working within a phase-gate development process ZOLL is a fast-growing company… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development , Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more