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Sr. Operations Engineer

Acton, MA

Posted: 06/09/2022 Industry: Engineering and Technical Job Number: 14494

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

 

Title Sr. Operations Engineer

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Perm
  • Pay rate: $113k
  • Job Location: Acton, MA
  • Job# 14494

 

 


Sr. Operations Engineer

 

Job Summary

Responsible for projects and to direct process support related to production of instruments. The position is expected to work independently and as part of a greater team, planning and implementing projects to support manufacturing including, but not limited to; equipment/material/process specification, validation, maintenance, and supply chain risk mitigation.

 

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Daily Engineering support/communication/coordination of instrument production
  • Read, write, train, and interpret instructions/specifications for electromechanical, high tech medical device including safety precautions
  • Creation and use of process engineering data and statistics to evaluate/improve processes.
  • Develop, maintain, and process changes to manufacturing procedures, maintenance instructions, and specifications used in manufacturing.
  • Lead and implement projects to reduce cost and supply chain risk, improve quality and instrument reliability.
  • Execute CAPA resolutions in manufacturing including at OEM
  • Advanced troubleshooting of device failures using electromechanical test and diagnostics skills including
    • Optical sub systems
    • High Voltage sub systems
    • Mechanical assemblies
  • Lead process FMEA to optimize efficiency and flow of laser manufacturing lines
  • Leverage tools like 5 whys, fishbone, etc for risk mitigation and corrective action
  • Develop Gannt charts and Visio process flows
  • Design tools and signage to drive manufacturing quality
  • Facilitate design for manufacturability/assembly/test and seamless execution of new product/process/equipment introductions at OEM, contract manufacturer and in-house
  • Provide thorough engineering solutions aligned with business needs leveraging process mapping
  • Serve as ops engineering lead on core team for new products (NPI) and facilitate effective introduction of new products to manufacturing
  • Represent Supply Chain Operations on cross-functional initiatives.
  • Develop and execute validation plans for process and design changes.
  • Develop and execute test plans/ root cause troubleshooting analysis at product and process levels.
  • Develop measurements and goals aligned with the business; monitor performance to identify support needs in addressing performance gaps in plant yields, OEE, machine/personnel utilization and process controls.
  • Drive analysis and continuous improvement of material use (yield performance).
  • Review analysis of equipment time use (OEE), identifies areas of opportunity and guides continuous improvement.
  • Provide development support and guidance on process control systems to optimize process performance and functionality for the operator.
  • Work cooperatively with Sustaining Engineering to develop project scopes and process engineering packages for improvement programs.
  • Create and implement cost savings annually via continuous improvement programs
  • NPI
  • Embody and deliver the “Exceptional Everyday”

 

Qualifications (Select the minimum qualifications required for this position to successfully achieve business requirements)

Education
Bachelor’s degree required

 

Education and experience combination:

Bachelor’s degree is equivalent to three (3) years of experience

 

Specific Area of Study: BSEE, BSME or BSIE, biomedical engineering

 

Experience
5 to 8 years relevant experience

 

Specific Related Experience: Instrument manufacturing engineering experience or equivalent, preferably medical device or other regulated industry. Produce related experience within manufacturing operations preferred, including an increasing level of responsibility.

 

Skills

  • Strong project management experience and Lean/Continuous improvement experience
  • Lean Six sigma Certification Preferred
  • Excellent soft skills – interpersonal savvy, listening, organizing, planning, time management, Learning on the fly, execution, focus, approachability, independence and good judgment, positive attitude
  • High energy
  • Hands-on Mechanical/Electrical Engineering skills are critical.
  • Software and optics knowledge beneficial
  • Communication—must be able to effectively communicate in both written and verbal forms, and at all levels in the organization
  • Familiarity with various advanced manufacturing process technologies
  • Demonstrated proficiency in time and project management
  • Teamwork - must be able to work effectively with fellow colleagues
  • Experience managing OEM and contract manufacturers in addition to in-house manufacturing
  • Failure Mode Effect Analysis, statistical process control, CAPA experience
  • Experience with regulatory, ISO and FDA with electromechanical medical devices extremely beneficial
  • Advanced program management
  • Strong skills working across global cultures.
  • Detail-orienteded with strong organization and time management skills to meet deadlines in a rapidly changing environment
  •  

 

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Sit; use hands to finger, handle or feel objects, tools, or controls.
  • Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
  • Lifting/pushing/pulling and carrying products weighing up to 45 pounds

 

 

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