Sr. Operations Engineer
Acton, MA 01886 US
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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
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
- Embody and deliver the “Exceptional Everyday”
Qualifications (Select the minimum qualifications required for this position to successfully achieve business requirements)
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
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.
- 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
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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