Senior Engineering Manager (Medical Device)

TL;DR

Senior Engineering Manager (Medical Device): Leading product development quality engineering for capital systems, clinical software applications, and surgical instruments within the Cranial and Spinal Technologies operating unit with an accent on pre-market and post-market activities. Focus on ensuring product quality, compliance, and continuous improvement in a regulated environment.

Location: Onsite in Lafayette, Colorado, United States

Salary: $168,800.00 - $253,200.00

Company

hirify.global leads global healthcare technology and boldly attacks the most challenging health problems facing humanity by searching out and finding solutions.

What you will do

• Plan, direct, and implement all aspects of the company's design and development of new medical device products or software systems.
• Develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards.
• Oversee the investigation and evaluation of existing technologies and guide the conceptualization of new methodologies, materials, machines, processes, or products.
• Direct the development of new concepts from initial design to market release and manage feasibility studies.
• Monitor documentation maintenance throughout all phases of research and development.
• Select, develop, and evaluate personnel to ensure the efficient operation of the function.

Requirements

• Requires a Baccalaureate degree.
• Minimum of 7 years of relevant experience with 5+ years of managerial experience, or an advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.
• Must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice to have

• Experience in developing Software in a Medical Device and Software as a Medical Device.
• Experience in mentoring, developing peers and/or direct reports.
• Experience in influencing cross-functional teams.
• Experience with audit front room (Notified Body, FDA) to describe products and processes.

Culture & Benefits

• hirify.global offers a competitive Salary and flexible Benefits Package.
• Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance.
• Health Savings Account.
• 401(k) plan plus employer contribution and match.
• Paid time off and Paid holidays.