Sr Principal Sustaining Hardware Engineer (Medical Device)

at  Fresenius Kabi

Job Summary
The Sr Principal Engineer performs sustaining engineering activities and technical project management related to commercial infusion pump products for the Ivenix Infusion System portfolio.
Apply specialized knowledge to manage and complete complex projects, including design and/or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generate and implement innovative solutions to highly complex problems.
Lead activities to meet business goals by driving quality improvements, addressing material obsolescence, meeting delivery requirements, and implementing cost reductions / product enhancements. Requires working in a team environment with cross-functional team members, such as manufacturing sites, marketing, quality, regulatory, and other R&D departments.
The position reports to the Director, Program Management. Provides guidance and leadership to junior engineers and manufacturing plant technical staff.
Responsibilities
Schedules and leads a project team through the planning and execution of a smaller project or defined piece of a larger project; includes constructing detailed and accurate project schedules, preparing resource / expense estimates, interfacing with development / manufacturing / procedures / support groups for project execution.
Displays standard engineering principles to resolve difficult problems, from conception to final design with team input.
Provide subject matter expertise in the areas of mechanical engineering related to electro-mechanical devices and associated manufacturing processes. Serve as Technical Approver for product design and/or manufacturing process changes related to infusion pump commercial products.
Plans, schedules, and leads project assignments in the evaluation, selection, and adoption of various engineering techniques, procedures, and criteria with minimal to no guidance.
Maintains the overall project schedule and budget.
Owns and maintains Change Control documentation to support the execution of the project.
Devises new approaches to complex problems through adoptions and modifications of standard technical processes.
Coordinates engineers / technicians / manufacturing plant personnel on assigned work.
Advise management on proposals and courses of action using both written and verbal methods.
Effectively operates in and facilitates cross-functional teams with minimal guidance.
Provide solutions and recommendations that reflect understanding of business objectives and cost implications.

Requirements

• Bachelor’s degree in Mechanical Engineering (or related Engineering degree) and 8+ years related experience in design and support of complex electro-mechanical devices, preferably in FDA regulated medical device industry
• Demonstrated project management skills with ability to manage / prioritize multiple concurrent projects
• Solid understanding of theories and practices utilized by other disciplines outside of primary area of expertise
• Demonstrated cross-functional leadership experience
• Excellent attention to detail and working knowledge of applicable regulatory guidelines and standards
• Strong problem solving and analytical skills
• Excellent written and verbal communication skills
• Experience with MS Project or similar project scheduling tool

Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Job Type: Full-time
Pay: $158,999.00 - $168,345.00 per year

Schedule:

• Day shift
• Monday to Friday

Work Location: Hybrid remote in North Andover, MA 0184

Please refer the Job description for details