Practice Manager - Medical Device
Posting ID: 7338387
Location: Troy, MI
The Practice Manager is responsible for the overall solution and delivery of center-based/onsite managed projects to our customers within an assigned industry segment while supporting managed delivery operations. They are responsible for meeting the strategic objectives including growth, customer satisfaction, and program KPIs for center-based projects within their assigned industry segments. The Practice Manager develops the right solution to meet customer needs by leveraging the capabilities of vertically aligned center based technical teams and collaborating with practice managers from other segments, delivery operations and business development. This role provides leadership and direction to program/project teams and ensures that all projects meet their cost, quality and timing requirements while building a robust operation to support our customer needs. This role is central to maintaining and growing relationships with key customer stakeholders and for providing overall governance for center-based/onsite project-based engagements. The Practice Manager will serve as an escalation point for technical, customer and personnel issues and interfaces with the customer at multiple levels, including executive level. Success in this role requires proven technical expertise combined with business acumen to deliver technical and business solutions that improve productivity and lower overall engagement costs.
- Collaborate with Business Development and Delivery Operations to develop center-based/onsite managed solutions for customers within the assigned industry segments while adhering to the Business Acquisition Process (BAP) as defined within EASi's Service Management Framework (SMF)
- Direct and manage project teams executing center-based/onsite managed projects within the assigned industry segments with overall responsibility for technical solution, cost, quality and customer satisfaction
- Ensure compliance to the BAP and Business Execution Process (BEP) within EASi's SMF for all center-based/onsite managed projects within assigned industry segments
- Monitor and manage project budgets; plan, control and allocate resources required to meet requirements
- Build and maintain strong customer relations at all levels of the organization
- Work with customer's technical stakeholders to facilitate workflow development, project scope development and risk assessment, issues resolution and work forecasting and planning
- Provide direction and innovation in service and/or process improvement, cost reduction and recommendations for business process optimization and profit improvement
- Build and oversee teams at multiple EASi sites/locations to ensure consistency of services, compliance with customer processes and standards and responsiveness to both customer and employee requirements
- Develop and implement employee performance and development plans to meet individual development and growth, and overall program goals; includes primary responsibility for talent management including overall hiring and termination decisions
- Ensure compliance with customer's training and policy requirements
- Maintain awareness for additional business opportunities and support pursuit of future business through quality results and escalation to internal stakeholders when additional business opportunities may present themselves
- Other duties as assigned by management
- Bachelor's Degree in Mechanical or Electrical Engineering; advanced degree is a plus
- Proven technical capabilities in developing solutions to engineering problems, defining project life cycles, managing deliverables/customer expectations and compliance to quality processes
- Experiences in all phases of Medical Device Product Development Life Cycle - Navigating, Managing, and Registering the Medical Device files with the FDA
- Experience with premarket submissions including 510(k) and PMA
- Med device regulatory knowledge and experience in ISO 13485, 21 CFR 820, EU MDR, ISO 14971 and IEC 60601
- Minimum 10 years of experience within Medical Devices product design and/or manufacturing required. Experience working with Class II, and III devices preferred.
- Strong understanding of and experience in quality, validation and remediation.
- A minimum of 7 years of experience managing engineering teams including training, development, mentorship and day-to-day responsibility.
- Proven written, oral and presentation skills and the ability to conduct meetings with high-level decision makers
- Ability to effectively communicate and partner across globally distributed cross-functional teams and roles in virtual environment
- Ability to travel when needed, up to 40 - 50 %
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
Recruiter: Daniel O'Dell
Phone: (260) 459-8016