Senior Product Design Transfer Analyst

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MESO SCALE DIAGNOSTICS, LLC.

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 1995

🏥 Gesundheitswesen

🏭 Fertigung

💼 Beratung

Healthcare • Manufacturing • Consulting

MESO SCALE DIAGNOSTICS, LLC. ist ein Entwickler und Hersteller von elektrochemilumineszenzbasierten Multiplex-Immunoassay-Kits, Detektionsinstrumenten, Software und zugehörigen Dienstleistungen für die biomedizinische und lebenswissenschaftliche Forschung. Das Unternehmen bietet hochsensitive Assay-Plattformen (z. B. V-PLEX, S-PLEX, U-PLEX), Instrumente (MESO SECTOR, QuickPlex-Serie), Reagenzien, kundenspezifische Assay-Entwicklung, Biomarker/CRO-Dienstleistungen und technischen Support für Anwendungen wie Immunologie, Onkologie, Neurodegeneration, Toxikologie und Organverletzung an. Die Produkte von MSD sind ausschließlich für Forschungszwecke bestimmt und bedienen akademische, pharmazeutische und biotechnologische Kunden.

Beschreibung

• 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.

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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