As part of the Healthineers Laboratory Diagnostics Manufacturing New Product Introduction (NPI) organization this person will manage the development and process validation of various electro-mechanical testing devices (referred to as Testers) for a or supplier’s manufacturing facility.
• Create a project management plan or plans describing how the Tester development engineering projects will be managed.
• Collaborate with R&D, New Product Introduction, and Instrument Manufacturing to define manufacturing Tester project scope of work
• Collaborate with New Product Introduction and Manufacturing to develop Complex Human Resource, Capital Material, and Expense Material Budgets ranging between $7 to $10 million
• Monitor and control project budgets to ensure no cost overruns occur
• Per the Human Resource budget, drive new team member sourcing and on boarding.
• Collaborate with senior level management to review, defend and facilitate budget financial approval.
• Create complex supplier outsourcing plans to leverage low cost off shore suppliers
• Collaborate with procurement to create, review and approve supplier contracts to outsource tester development effort.
• Plan all material and supplier engineering service procurement effort
• Create project schedule baseline as well as monitor and control project schedule
• Create and implement a project risk management plan
• Executive project risk mitigation plans
• Perform periodic project quality assessments ensure compliance to procedures
• During development track the capital asset value of each manufacturing Tester and Power Cart instance
• After each Tester is validated and in production use, collaborate with finance to capitalize each Tester instance as a Capital Asset
• Periodically report on project schedule and cost status to senior management
• Create and implement escalation plans to prevent schedule, cost or quality issues.
• Travel to each instrument R & D development site and supplier site(s) to track project status and identify project risks as well as issues
• Domestic and international travel frequency is 35%
• 7 to 10 years of product development experience
• 3 years experience in managing engineering projects worth between $5 to $7 million
• 5 years experience in working with large organizations with complex management structures
• 5 years experience working in a stringent quality regulated environment
• Experience in quality audits
• 5 years of medical device product development
• 3 years experience using SAP
Minimum Educational Requirements
• Bachelor of Science in Mechanical or Electrical engineering
Preferred Educational Requirements
• Master of Science in Mechanical or Electrical engineering
• Certified Project Management Professional (PMP) through the Project Management Institute (PMI)
If you have the above qualification and are available to look into this opportunity please send your updated resume along with your contact# and I will call you back to discuss further.
APN Software Services, Inc .
39899 Balentine Drive, Suite 385, Newark, CA 94560 .
Direct: 510.623.5049 | Fax: 510.623.5055 | Email: firstname.lastname@example.org