The person in this position assumes responsibility for leading an engineering team with the objective of improving on current products and supporting current products throughout the product lifecycle. This person provides both technical review and management oversight for areas of design control and risk management. Additionally, this person provides guidance, leadership, and mentorship to engineers and project team participants.
• Provides technical oversight and review for Design control and Risk Management, including design plan deliverables, user needs and design input requirements, V&V testing, and risk analysis.
• Engage CBI departments, business partners, and healthcare professionals to gather user requirements, design requirements, and coordinate development activities.
• Constructs Service Agreements for partner projects.
• Foster continuous improvement and leads initiatives to improve functional efficiency of CBI processes.
• Communicate resource needs, tasks and changing priorities to other areas of the company.
• Encourages innovation in device design and usability.
• Routinely interacts with healthcare professionals and partners to expand knowledge of end-user requirements.
• Works to resolve project obstacles and challenges.
• Ensures accuracy in effort-tracking and accounting for Service Agreement projects.
• Conduct and coordinate engineering activities to develop products according to project timelines.
• Provide project management education, resources and tools to ensure engineering teams achieve goals per customer request.
• Provide leadership to the engineering team to ensure project timelines are achieved.
• Mentors Engineers and other functional area project members.
• Conduct and coordinate design control and risk management activities, including reviewing the overall design risk profile and ensuring risks are appropriately controlled and mitigated.
• Encourages effective communication in transfer of designs to Operations.
• Conducts employee performance evaluations and wage reviews. Ensures employee training is current and adequate for the job duties assigned.
• Remain current and apply the understanding of FDA, ISO 13485/14971, and Quality System Requirements.
Ensures design control procedures and risk management procedures are efficient and effective; update systems accordingly for new compliance requirements.
Communicate project status to partner representatives and other CBI functional areas.
• Master's degree in engineering with emphasis in chemical or biomedical engineering. Other relevant engineering disciplines may be considered with commensurate experience.
• Five to ten year's industry experience in medical device development preferred; or, directly relevant educational/academic experience may be accepted.
• Minimum of 2 years personnel development/supervisory and management experience directly with engineers.
• Proven ability to lead and manage projects.
• Proven ability to communicate and work constructively with colleagues to establish and achieve mutual goals.
• Sufficient background to generally understand medical and biotechnology terminology.
• Excellent written and verbal communication skills.
• Proven ability to manage multiple projects.
• Must be able to perform the essential functions of the job , with or without reasonable accommodations
• Physical demands are typical of an office and classroom environment
• Limited exposure to hazardous chemicals used in the manufacture of the product. Willing to work with material derived from animal tissues.