Job Description
Essential Functions:
Directing new product development
- Perform literature searches for relevant new techniques and trending biomarkers for new product applications
- Attend conferences, trade shows, and seminars to build working relationships with industry partners and Key Opinion Leaders
- Develop project plans and track milestones
- Direct laboratory technician(s) to perform production and testing
- Analyze data and compile results to present internally and externally
- Effectively document records of research activities to preserve continuity
Managing existing products through Design Control
- Direct the activities of the Design Control Board and maintain proper documentation
- Understand quality requirements related to the area
- Specify, authorize, and purchase lab equipment and supplies
- Understand and complies with ethical, legal, and regulatory requirements applicable to MDI
Success Factors
- Good knowledge of scientific principles, methods, and techniques
- A thorough understanding of human blood and serum biochemistry and familiarity with current literature
- Ability to troubleshoot process and product anomalies
- Ability to interpret and communicate scientific results to a broad range of individuals
- Problem solving, creative thinking, organizational, and multi-tasking skills
- Proven ability to work as part of a team
- Solid written and verbal communication abilities
- Self-starting and accountable to set goals, implement project plans, and monitor progress
- Proficiency with computers and Microsoft Office Suite
- Working knowledge or experience with ISO 13485:2016 standards and FDA regulations preferred
- Prior medical device industry experience preferred
- Prior knowledge of clinical chemistry applications preferred