Engineering Manager – R&D and Transfer

Engineering Manager
– Advanced Manufacturing (Development team and Transfer through Manufacturing Team)

Our client, a well-respected and fast growing $750M Revenue Healthcare Industry Success, has an opening for an Advanced Manufacturing Engineering Manager.

In this role, you will lead the team and the organization to successful market launch and manufacturing transfer of new products.

The Manager is responsible for defining the objectives, scope, assumptions, project plan and timeline for development projects.

The role includes leading a team of direct technical reports, and will identify, gather, and manage shared and cross functional resources to ensure project success.

Responsibilities:
Builds, manages and improves a high caliber technical team
Operates with independence to develop novel solutions and define significant technical and business opportunities through team leadership
Ensures that all project deliverables are completed with high quality and in a timely fashion
Identifies, develops and launches new products through internal and external activities
Leads more than one project at any one time
Leads cross-functional teams from project conception through launch and transfer to manufacturing
Creates project plans and timelines.

Stays on time and on budget
Participates in due diligence activities as necessary
Skills:
Leadership
Thought leadership, people leadership, leading to good business decisions
Communication
Ability to present technical materials to non-technical personnel up to President effectively with strategic impact
Conflict resolution
Achieving results
Ability to manage those with technical skills appropriate to multiple disciplines (design, mechanical, electrical, software, biomedical)
Ability to hire, lead and develop team members
Ability to marshal resources and lead cross functional teams on projects of significant scope.

Ability to understand discipline specific tools well enough to manage team members ( i.e.

Solidworks , p-Spice, debuggers, Minitab, GD&T, etc.)
Knowledgeable of and work within FDA, ISO, CSI and other relevant standards.

Experience with class I and II devices preferred
Design, fabrication, and testing proficiency with common manufacturing techniques for high volume, disposable parts – machining, injection molding, extrusion, stamping, casting, MIM, etc.

Experience inventing, innovating, and launching products
Proficiency with analysis and problem solving
Proficiency with design of experiments, protocol and model development, testing and documentation
Experience in clinical and pre-clinical settings
Ability to utilize common office and web-based software (email, spreadsheets, word processing, presentations) effectively
Impact:
Work leads to the launch of strategically important new products
Work leads to the continual improvement and development of direct reports and other team members
Work contributes to due diligence and decisions regarding acquisitions
Interactions:
Interacts with R&D staff and cross-functional partners (Marketing, Manufacturing, RA, QA, labeling, legal, etc.) daily
Interacts with customers and vendors
Will interact with organizational leaders on a frequent basis
Accomplishments:
Led the launch of numerous products in the medical device field of moderate to high complexity
Contributed as team member or leader to sustaining engineering activities
Has participated in the selection and hiring of engineering talents
Qualifications:
Bachelor's Degree in Engineering with 10+ years industry experience, Master's Degree in Engineering management or business with 5+ years industry experience, PhD with 5+ years industry experience.

Thorough understanding of design controls
Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements
Passing a background check which may include verification of prior employment, criminal conviction, educational and driving records
Type: direct hire