- Merck (West Point, PA)
- …Reporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform Packaging and ... ensure compliance with relevant regulations and standards. Ensure thorough engineering, medical device and packaging science is applied to deliverables for… more
- Merck (West Point, PA)
- …and support of Autoinjectors. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, and ... manufacturing, ensuring robust introduction, qualification, and performance monitoring. + ** Regulatory Compliance ** : + Collaborate closely with...a minimum of 20 years of hands-on experience in medical device engineering, with a focus on… more
- Merck (West Point, PA)
- …in alignment with the company's business goals, and quality and regulatory compliance . **Essential Duties and Responsibilities:** _Strategic Leadership and ... conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional...preferred. + Minimum of 10 years of experience in medical device or combination product engineering, with… more
- Merck (West Point, PA)
- …and Skills: . **Manufacturing** - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. ... of lean principles, equipment design, and preventative maintenance. . ** Regulatory ** - Global regulations and compliance requirements...development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device preferred to Pharma) OR ... well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care...Progressive leadership experience in the health care setting. + Medical Safety ( Medical Device preferred… more
- Merck (West Point, PA)
- …and Qualifications:** + Minimum of 10 years' experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3-5 years in a leadership ... equipment design, development and qualification. + Strong background in the medical device , combination product, pharmaceutical packaging equipment and… more
- Penn Medicine (Philadelphia, PA)
- …working with medical hardware, software and equipment products + Understand medical device usage within a health system environment + Experience working ... tasks that have been mastered. + Uses understanding of Regulatory and Safety requirements to communicate Biomed compliance...and high risk equipment, utilizing a strong understanding of medical device integration and networking. + Correctly… more
- Penn Medicine (Philadelphia, PA)
- …for low, medium and high risk equipment, utilizing a strong understanding of medical device integration and networking. Correctly and efficiently applies basic ... with tasks that have been mastered. Uses understanding of Regulatory and Safety requirements to communicate Biomed compliance... medical hardware, software and equipment products Understand medical device usage within a health system… more
- Merck (West Point, PA)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance . To act as master data stewards and support ... **Required Skills and Experience:** + Subject matter expertise in packaging and/or medical device and combination product components as well as development… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ... ensure compliance + Responsible to build and improve key business...+ Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.preferred and +… more