Senior Manufacturing Engineer (Onsite)

Position Overview:

The Plant Manufacturing Engineer is a critical member of the plant engineering and operations teams.  This role is responsible for reliability engineering, monitoring, and standardizing the manufacturing process, anticipating and resolving bottlenecks to capacity, driving uniformity of maintenance and operations principles, identifying and implementing cost and waste reductions, and general continuous improvement of the site. The successful candidate will have strong structured problem-solving skills of complex component and machine interactions and be comfortable working hands-on with automation machinery.

Responsibilities:

• Accountable to driving maintenance process improvements in support of Insulet’s primary manufacturing objectives: Best Quality, Best Service, Best Cost.

• Autonomously interprets data to drive plant decision making and prioritization of reliability efforts.

• Plan, execute, and manage efficiency improvement projects.

• Develop and implement process controls to stabilize and sustain equipment reliability.

• Develop and deliver training to build the capability of the plant engineering and operations teams as part of continuous improvement efforts.

• Independently maintains and publishes operating scorecard to track and trend projects/improvements.

• Create and modify preventive maintenance tasks and work plans to move unplanned emergency events to planned maintenance events.

• Maintain direct hands-on interaction with the manufacturing equipment including station set-up and troubleshooting using hand tools, measurement tools, machine documents, specialty gages, and high-speed filming equipment

• Provide input and support for technology transfer and equipment design reviews.

• Ensure compliance with safety rules, quality policies, and employee guidelines

• Maintain a cGMP compliant environment and operate within FDA guidelines for 21CFR820 manufacturing.

• Serves as back-up Maintenance Operations Manager. Off-shift support may be required.

• Perform other duties as required

Behavioral Competencies:

• Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions

• Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively

• Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment

• Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate and implement solutions.

• Initiative – Makes decisions and takes actions appropriately.  Willing to take risks as circumstances require

• Planning Skills – Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals

• Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience

Education and Experience:

Minimum Requirements:

• BS in Mechanical, Industrial, or equivalent field with 5+ years of manufacturing experience, preferably in a medical device or highly regulated environment.

• OR MS in Mechanical, Industrial, Electrical Engineering, or equivalent with 3-5 years of manufacturing experience, preferably in a medical device or highly regulated environment.

• Hands-on experience in setup and operation of automated production equipment

• Advanced proficiency in MS Office (MS Word, Excel, Power Point, Outlook) and data analytics tools

• Process oriented and uses data to make decisions

• Demonstrated success using problem solving methodologies such as A3, PDCA, DMAIC, etc.

• Ability to fulfill job responsibilities in a fast-paced/high-volume production environment

• Mechanical aptitude, technical ability, ability to read and understand technical drawings and manuals.

• Hands-on technical ability with assembly methodologies including locational methods, assembly setup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc.

Preferred Skills and Competencies:

• Experience with SOLIDWORKS or AutoCAD.

• Technical knowledge of cam driven linkages, discrete component assembly, and automation

• Familiarity with machine user interfaces (HMIs / GUIs)

• Familiarity working within cGMP guidelines and ISO 13485/21FDA820 regulations.

• Experience working in a regulated industry, in particular consumable products. 

• Have strong interpersonal and communication skills

• Excellent attention to detail, organizational skills, and rigorous process discipline

• Thirst for knowledge and intense curiosity

Physical Requirements:       

• Required to stand up to 75% of working time per shift, with walking up to 50% of working time per shift

• Required to reach above shoulder and below waist frequently

• Required to push and pull

• Ability to lift up to 35lbs occasionally

• Able to work off shifts (nights/weekends) as needed, 10% max

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $94,700.00 - $142,100.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.