Sr. Manufacturing Engineer (Fraser, MI)

Job Overview

Plans and oversees engineering activities and projects within the department. Develops and directs teams to design, optimize, and implement new manufacturing processes and equipment into production. Drives continuous improvement efforts in process design, cost savings, quality improvements, and resource utilization.

Job Responsibilities and Essential Duties:

• Responsible for engineering projects, incorporating newest manufacturing technologies & methods, resolving engineering problems, and improving existing manufacturing processes/equipment.
• Responsible for upstream equipment qualification deliverables (URS, FAT, SAT, etc.).
• Prioritize and communicate project priorities based on current business needs.
• Responsible for achieving product quality, productivity, and standard cost goals.
• Maintain compliance with all regulatory standards for product and personnel safety.
• Guide, direct, and coordinate facility moves, process transfers, and new equipment installations ensuring improved product quality, manufacturing efficiencies, production yields, and reduce product costs.
• Support nonconformance investigation.
• Responsible for identification and communication with external machine builders and systems integrators.
• Support manufacturing objectives as specified by the management team by promoting investigation, inventiveness, creativity and solutions to various process, implementation, and material flow/control problems.
• Communicate new ideas, technology advances, and opportunities to management team for review, evaluation and action.
• Responsible for developing and maintaining department expense and capital budget(s).
• Create and maintain a safe environment. Ensure legal requirements and safety policies are enforced.
• Assist in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities:

• Ability to work with flexible and changing production schedules.
• Must be able to collaborate effectively with others, and work well within cross-functional teams and across multiple sites, as applicable.
• Self-motivated and have the ability to manage projects and problem solve on a regular basis.
• Highly organized with strong project management and technical abilities.
• Demonstrated ability to develop strategies that will help build a positive manufacturing environment.
• Ability to communicate with machine builders and system integrators.
• Strong negotiation skills required.
• Strong computer skills, including MS Office applications (Word/Excel) are required.

Minimum Requirements:

• Bachelor’s degree in Engineering, Industrial Management, or related field or equivalent.
• Minimum 10 years of experience within a manufacturing or process development environment, preferably within the Medical Device Industry.

Quality Requirements:  

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are performed in an office/manufacturing/warehouse environment. May require the use of personal protective equipment as dictated by the work area.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The salary range for this position is between $94,000-$118,000/annually depending on experience and location, with a 5% STIP bonus

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