Engineer II, Production (Merrimack, NH)
Getinge
Summary
Supports the commercialized production of medical devices. Works within manufacturing engineering functions to provide technical support for the quality of the product, process development, continuous improvement, and process control.
Job description
Job Responsibilities and Essential Duties
- Works in team setting and works independently with minimal oversight.
- Supports production / manufacturing.
- Supports / Leads scrap reduction / equipment downtime reduction, and Lean efforts.
- Developed manufacturing methods into work instructions and associated training for transfer into production.
- Develops required maintenance and calibration instructions for manufacturing equipment and creates required equipment documentation.
- Provides higher level assistance for equipment design for producing medical devices and components.
- Perform process development and validation including IQ, OQ, PQ, EAT, & TMV.
- Perform process improvement initiatives.
- Supports / Leads non-conformance investigations, CAPA activity, OOT’s, Customer complaints, PFMECA’s, MES, and equipment troubleshooting.
- Executes complex change orders (ECO’s) related to process and equipment documentation.
- Analyzes and documents test results for development and pilot production runs.
- Generates and manages PSO’s.
- Specifies and executes equipment and tooling verifications and equipment acceptance tests.
- Contributes to the team effort by accomplishing related tasks as necessary.
- Support business metrics.
- Participate / Lead large scale projects.
- Protocol and report writing.
- Identify, Lead, and Resolve component / supplier related problems.
- Perform other related duties as required.
- Performs data analysis / root cause investigations with data driven approach.
Minimum Requirements
- Bachelor’s Degree in Engineering, or equivalent work experience.
- Three years related manufacturing experience (medical device field is preferred).
- Must be highly skilled in equipment troubleshooting (Electro-mechanical)
- Must possess good problem solving skills and data analysis skillset.
- Demonstrated knowledge of MS Office applications (Word/Excel/PPT) is required (Minitab experience is preferred).
Required Knowledge, Skills and Abilities
- A demonstrated knowledge and understanding of Quality Assurance Methods and good analytical and problem solving skills are required.
- Good analytical and problem solving skills.
- The ability to organize, prioritize and adapt.
- Multi-tasking capabilities in a fast paced environment.
- Experience working with FDA requirements preferred.
- Experience working within a medical manufacturing environment preferred.
- Working knowledge of statistical process control and lean manufacturing preferred.
- Working knowledge of computer aided drawings (CAD / solid works) preferred.
- Excellent communication skills (oral and written)
Requirements
- Bachelor’s Degree in Engineering, or equivalent work experience.
- Three years related manufacturing experience (medical device field is preferred).
- Must be highly skilled in equipment troubleshooting (Electro-mechanical)
- Must possess good problem solving skills and data analysis skillset.
- Demonstrated knowledge of MS Office applications (Word/Excel/PPT) is required (Minitab experience is preferred).
- A demonstrated knowledge and understanding of Quality Assurance Methods and good analytical and problem solving skills are required.
- Good analytical and problem solving skills.
- The ability to organize, prioritize and adapt.
- Multi-tasking capabilities in a fast paced environment.
- Experience working with FDA requirements preferred.
- Experience working within a medical manufacturing environment preferred.
- Working knowledge of statistical process control and lean manufacturing preferred.
- Working knowledge of computer aided drawings (CAD / solid works) preferred.
- Excellent communication skills (oral and written)
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) matching
- Paid time off
- Wellness initiative
- Health assistance resources
- Life insurance
- Short term disability
- Long term disability
- Flexible spending accounts
- Commuter benefits
- Parental leave
- Caregiver leave
- Tuition reimbursement
Company overview
Getinge AB is a leading Swedish medical technology company founded in 1904 and headquartered in Gothenburg, Sweden. As a publicly traded company listed on Nasdaq Stockholm, Getinge specializes in developing and manufacturing advanced medical devices and solutions for healthcare and life sciences industries. The company operates through three core business areas: Life Science, Acute Care Therapies, and Surgical Workflows. Getinge's comprehensive product portfolio includes ventilators, heart-lung machines, anesthesia systems, surgical tables, sterilizers, washer-disinfectors, bioreactors, and digital health solutions. With approximately 12,000 employees worldwide, operations in 40 countries, and sales in over 135 countries, Getinge has established itself as a global leader in medical technology. The company maintains manufacturing facilities across Europe, Asia, and North America, with the United States representing its largest market. Getinge's commitment to innovation and patient safety has made it a trusted partner for hospitals, research laboratories, and pharmaceutical production facilities worldwide, dedicated to improving clinical outcomes and optimizing healthcare workflows.