Senior Product Design Transfer Analyst

Job not on LinkedIn

🕒 April 2

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

MESO SCALE DIAGNOSTICS, LLC.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1995

🧬 Biotechnology

🔬 Science

Biotechnology • Science

MESO SCALE DIAGNOSTICS, LLC. is a developer and manufacturer of electrochemiluminescence-based multiplex immunoassay kits, detection instruments, software, and related services for biomedical and life-science research. The company provides highly sensitive assay platforms (e. g. , V-PLEX, S-PLEX, U-PLEX), instruments (MESO SECTOR, QuickPlex series), reagents, custom assay development, biomarker/CRO services, and technical support across applications such as immunology, oncology, neurodegeneration, toxicology, and organ injury. MSD’s products are marketed for research use only and serve academic, pharmaceutical, and biotechnology customers.

📋 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.

🎯 Requirements

• 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

🏖️ Benefits

• 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