Engineering Manager Ekos
MAIN PURPOSE OF JOB
Manage Engineering team to develop new products and product improvements through
application of engineering fundamentals, applied research, risk assessment, innovation, and
Design for Manufacturability (DFM) principles.
Prioritize engineering goals with Senior Management to achieve corporate strategic
objectives, supporting EKOS product development activities.
Support both R&D and sustaining engineering project transfer to manufacturing through
development of initial designs, production processes, documentation, and equipment.
MAIN JOB DUTIES/RESPONSIBILITIES
? Exhibit BTG core values (Openness, Accountability, Teamwork, Integrity, Delivery, and
Continuous Learning) in all activities.
? Communicate corporate strategy and goals to the engineering team.
? Identify, execute, monitor, and communicate new product development projects and
introduction into manufacturing.
? Assist in and/or manage functional deliverables and ensure compliance with product
development (PDP) and quality system requirements.
? Ensure continued intellectual property development from self and staff.
? Provide guidance and training to staff, assist subordinates in attaining career goals,
motivate individuals to achieve results, and recruit and maintain a high quality staff.
? Contribute to development of departmental budgets and monitor spending.
? Assist in identifying and developing departmental instrumentation and tooling.
? Assist in and/or determine appropriate staff levels, schedules and resources. Works with
project managers to understand priorities and plan resource and time allocation
accordingly to meet completion dates and R&D deliverables.
? Work interactively with internal resources, such as Manufacturing, Purchasing and
Quality Assurance, and OEMs as part of the PDP process.
? Maintains and enhances cross-functional team relationships, resolving technical issues.
? Foster a diverse workplace that enables all participants to contribute to their full
potential in pursuit of organizational objectives.
? Generate design history documents in compliance with GMP, QSR, ISO, and company
? Manage evaluation activities regarding selected design concepts to meet functional,
clinical, and customer needs.
? Strong understanding of new product development technologies and application to company
strategic clinical presence and needs.
? Provide input for the creation/modification of Product Specifications in alignment with
Customer Requirements. ? Oversee testing and theoretical analysis of products to determine product safety and
? BS in Engineering (ME, IE preferred). Advanced engineering degree desired.
? 10+ years of successful engineering experience in a medical device or precision electro mechanical product environment.
? 5+ years in a direct supervisory role.
? Capable of fluidly scaling between hands-on/ detail oriented support and highly
? Expertise in relevant medical device materials, fabrication, equipment, and testing.
? Catheter design and development experience preferred.
? Expertise in GMP, ISO 13485, MDD, and QSR requirements.
? Strong statistical analysis and experimental design skills, DoE experience highly
? Expertise in Lean /Six Sigma techniques preferred.
? Presentation, project management, and technical writing skill excellence.
? Demonstrated SolidWorks capability.
? Ability to travel when required.
? Selection of engineering direction and priorities.
? Signature authority for Document Change Orders (DCOs), protocols and reports, and
Non-Conformance Reports (NCR) associated with Material Review Board (MRB).
? Development of training plans for engineering staff.
? Supervision, hiring and discipline of engineering staff, including technicians.
? Selection and purchase of equipment, materials and supplies with one-over review.
? Selection of facility systems, as applicable.
? Selection of design direction, with team member involvement and with design review.
? Timeline and specification planning, with team member involvement and with design
? Develop and approve documentation of engineering testing and results, with
conclusions and recommendations in reviewed reports.
||11911 North Creek Parkway South |
Bothell, WA 98011