Medical Device Jobs in Bedford (MA)
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Search Results - Medical Device Jobs in Bedford (MA)
Oxenham Group LLC-Bedford (MA)
Senior Implementation Specialist – JAMA ALM
Position Overview
We are seeking an experienced implementation specialist with deep technical expertise in deploying JAMA ALM within medical device manufacturing environments. This role involves working...
resume-library.com -
Infraredx, a Nipro Company-Bedford (MA)
and compiling documents, as well as responding to questions and requests from the FDA.
• Determine and document change assessments for EU Class III & IIb devices to ensure compliance with the EU Medical Device Regulation.
• Plan and prepare submissions for EU...
mindmatch.ai -
Katalyst Healthcares & Life Sciences-Bedford (MA)
Responsibilities:
We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning...
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Anika-Bedford (MA)
utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines. Reporting to the Director of Engineering...
mindmatch.ai -
Katalyst Healthcares & Life Sciences-Bedford (MA)
in regulated industries (medical device, pharma, or biotech).
Strong background in Computer System Validation (CSV) & Software Development Life Cycle (SDLC) experience building validation programs from scratch is a huge plus.
Experience with modernizing...
resume-library.com -
Bedford (MA)
regulations and time lines.
• Leads the regulatory team in the assessment of device modifications to IL-labeled medical devices, filing with US FDA and Health Canada directly (as needed), ensuring that necessary country regulatory filings are made prior...
icims.com -
Bedford (MA)
design iterations. On the Electrical side, candidates will review schematics, rework PCBs, and gain valuable lab experience. This position will provide the candidate knowledge of a full product development lifecycle of a regulated medical device company...
icims.com -
Bedford (MA)
and presentation skills
• Proficient in Microsoft Office Suite, particularly PowerPoint and Excel, knowledge of SAP preferred
• Familiarity with the context of In-Vitro Diagnostics/ Medical Devices regulations
Management has the discretion of substituting relevant...
icims.com -
Bedford (MA)
Overview:
Position Summary:
Under general supervision, this position supports the production of medical devices. Duties include a variety of technical support and administrative duties related to complex electro-mechanical test equipment and hand...
icims.com -
Bedford (MA)
in a manufacturing environment with minimum 7 years of supervisory experience preferred
• Previous experience within a regulated medical device or pharmaceutical environment preferred
• Strong knowledge of Excel; MS Office, required
Management has the discretion...
icims.com -
Bedford (MA)
level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired.
Additional Skills/Knowledge:
• Language: Proficiency in English language required
International Mobility:
• Required...
icims.com -
Bedford (MA)
Knowledge & Experience Required for the Position:
Education:
• Bachelor's degree or equivalent in engineering or science
Experience:
• A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory...
icims.com -
Bedford (MA)
or higher, preferably in science and/or regulatory
Experience:
• Minimum of 5-years' experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years' experience with an advanced degree
Additional Skills/Knowledge...
icims.com -
Bedford (MA)
and risk management activities - in medical device or healthcare domain.
• Cyber security training and certification such as CISSP/CISM.
• Experience in cross-functional cyber security activities including intrusion detection, security tools...
icims.com -
Bedford (MA)
vision.
• Basic Project Management skills.
• Strong oral and written communication skills.
• Experience in Software Medical Devices development that follows ISO 13485, IEC 62304 / 21 CFR Part 820.30 highly desired.
• Sound understanding of the Linux...
icims.com -
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