Biocompatibility Manager Jobs in Indiana (NOW HIRING)

Summary:

Responsible for managing all aspects of a new product launch for surgical instruments, implantable devices, and delivery systems from opportunity review to production transfer. The position will lead customer and internal activities facilitating the product launch between the customer, supply chain, and Paragon. 

Duties and Responsibilities:

• After project award, single point of contact for customer interface and Paragon collaboration, including primary technical representative for Paragon Medical with Client to negotiate product design and process deliverables.
• Drives project proposals at project initiation.
• Oversees quoting activities including the process outline and end to end costing process.
• Leads project requirement checklists through justification and/or rationalization of activities associated with product launch.
• Owns project planning and timeline execution, including managing project team workload, activities and scope.
• Leads Design for Manufacturability (DFM) with the Client and coordinates DFM discussions internally.
• Supports NPD engineering activities and oversees Device Master Record (DMR) development and accuracy with associated process development and testing.
• Guides pFMEA development and team discussions along with managing the risk mitigation activities and testing.
• Supports purchasing in supply chain integration.
• Leads pre/postproduction meetings.
• Responsible for timing, profitability of process, NRE investment, project costs throughout the NPD process.
• Responsible for accurate information released to production to include, but not limited to, router, inspection sheets, in process prints, and fixtures.
• Primary support for Quality requests.
• Works proactively with the team to share best-practices, and lessons learned.
• Understands project schedules for all projects that are within the department.
• Drives the implementation of the PMO methodologies corporate-wide.
• Responsible for determining NPD lock down completion and obtaining optimum transfer of new product over to the production department.

Education:

• Minimum 4 year Bachelors Degree 

Experience:

• 5-10 years leading product development. Medical device experience preferred

KSA's:

• Strong organizational, follow-through, and attention to detail skills required.
• Strong communication skills (oral, written, and presentation) required.
• Ability to handle multiple priorities simultaneously.
• Self-starter/motivator for personal and professional growth.
• Ability to form partnering relationships with peers and multiple levels throughout the organization.
• Understanding of geometric dimensioning and tolerance (GD&T) requirements for application to design projects.
• Ability to apply strong engineering principles, theories, concepts and techniques to tasks and projects that may result in new application and industry standards or practices.
• Experience with tight tolerance methods in machining and measurement system applications, blueprint reading, GD&T, working knowledge of short run process control methods, statistical analysis, DOE, ISO standards and FDA quality system regulations.
• Previous experience in similar leadership role is required.
• Windows-based computer knowledge is required.
• Minimum two years of experience in project management (strategic/tactical planning and implementation capabilities) coupled with strong technical and conceptual aptitude required. Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO 13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic knowledge of the human anatomy preferred.
• Knowledge of various metal and polymer materials as well as testing specifications preferred.