Senior Product Design Transfer Analyst

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MESO SCALE DIAGNOSTICS, LLC.

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 1995

🏥 Santé

🏭 Fabrication

💼 Conseil

Healthcare • Manufacturing • Consulting

MESO SCALE DIAGNOSTICS, LLC. est un développeur et fabricant de kits de tests immunologiques multiplex basés sur l'électrochimiluminescence, d'instruments de détection, de logiciels et de services connexes pour la recherche biomédicale et en sciences de la vie. L'entreprise offre des plateformes de test extrêmement sensibles (par exemple, V-PLEX, S-PLEX, U-PLEX), des instruments (séries MESO SECTOR, QuickPlex), des réactifs, le développement de tests sur mesure, des services de biomarqueurs/CRO, et un support technique pour des applications telles que l'immunologie, l'oncologie, la neurodégénérescence, la toxicologie et les lésions d'organes. Les produits de MSD sont destinés exclusivement à la recherche et servent des clients dans les milieux universitaires, pharmaceutiques et de biotechnologie.

Description

• Attend design reviews and other project related meetings • Effectively communicate configuration considerations for product design • Provide feedback on timelines and potential processing constraints • Work with development teams to fully define the scope of configuration activities needed for a project • Coordinate with various departments and functional groups to ensure the accuracy of information provided by development team • Communicate documentation issues and solutions to product development team • Generate documentation related to impact assessments and implementation preparation • Generate Parts Maps for determination of impacts to existing product, determination of new product requirements, and assessment of the overall implementation plan. • Prepare all documents required for Configuration (e.g. Bill of Materials (BOM), Routings, Product Specifications, etc.) • Lead cross-functional problem-solving efforts for Product Transfer/Change Control Activities • Identify process gaps and inefficiencies and provide recommendations for solutions • Support departmental training program and development of new tools • May lead and/or mentor others • Ensure compliance to document and record control according to all MSD quality, ISO and regulatory requirements • Write SOPs as needed • Specific duties may vary depending upon departmental requirements.

🎯 Exigences

• Bachelor’s degree in Science, Engineering or related field preferred • Minimum of 5 years of experience working in a Manufacturing, Research Development, Product Transfer, Quality or other related department is required • Minimum of 2 years of experience with product commercialization including hands-on work in quality assurance, manufacturing, product transfer, and/or product development strongly preferred • Experience in pharmaceutical, medical device or biotech industry preferred • Experience with Change Control and/or Document Control processes is required • Experience with ERP systems such as JD Edwards EnterpriseOne is desired • Experience with PLM systems such as Aras Innovator is desired • Experience with training or mentorship is desired

🏖️ Avantages

• Medical, dental, and vision coverage • Prescription benefits • 401(k) plan with company matching • Flexible spending accounts • Company-paid short- and long-term disability insurance • Group life and accidental death and dismemberment insurance • Paid vacation • Paid sick leave • Paid holidays • Paid parental leave • Employee assistance program • Fitness club membership contribution • Pet insurance • Identity theft protection • Home and auto insurance discounts • Optional supplemental life insurance