Merrimack, New Hampshire

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. A career at Getinge provides career opportunities that both inspire and challenge. Here, you can make a difference every day.

The Process Engineer II will support the Manufacturing Engineering and Product Development team by contributing to the process development, optimization, and validation of new and existing medical device manufacturing methods. Manufacturing processes the team is exposed to include but are not limited to resin extrusion, thermal welding, laser marking, leak testing, oven sintering, vibration welding, and skiving.

Who You Are:

Some one withexperience in process development, optimization, and compliance for medical devices and components, or similar. This may include experience with or familiarity of manufacturing, design controls, test method development and process validation. You are expected to have the aptitude for both hands-on development of manufacturing processes/equipment as well as analytical, interpersonal, and technical writing skills and the desire to further develop this skillset. You possess the ability to thrive in a fast-paced, well resourced, multidisciplinary environment supporting the team effort to drive project completion andstrive to play an active role in company objectives as well as your own personal growth and development.Flexible work hours and options are available however the position is expected to have in office responsibilities.

Job Responsibilities and Essential Duties
  • Provide input to Product Development on new product designs to address Design for Manufacturing (DFM) and Design for Assembly (DFA) requirements.
  • Act as a liaison between Product Development, Manufacturing, and Manufacturing Engineering to assure that project deliverables are communicated and agreed upon.
  • Assess process failure risks and institute methods of detection and mitigation.
  • Develop & optimize processes required for new products & equipment.
  • Work with internal design/equipment engineers and/or outside equipment vendors to specify, purchase and develop new manufacturing equipment and tooling.
  • Work with validation and quality engineers to develop validation plan for new equipment / processes.
  • Maintain compliance to Quality System and regulations for new processes and equipment.
  • Complete protocols and reports for Equipment Acceptance Testing (EAT), Installation Qualifications (IQ), and Operational Qualifications (OQ).
  • Collaborate with other disciplines as needed to execute Performance Qualification (PQ) activities.
  • Coordinate pilot production / pre-release manufacturing.
  • Work closely with Manufacturing and Manufacturing Engineering to release new processes and equipment into production.
  • Work closely with Manufacturing and Manufacturing Engineering to support new processes and equipment that have been recently released into production.
  • Create and implement required documentation including but not limited to; equipment history files, manufacturing procedures, test methods, BOM's, routings, etc.
  • Responsible for change orders (ECO/DCO's) required to release and/or update controlled items.
  • Assist in special projects as needed.
  • Contribute to team effort by accomplishing related duties as requested.

Minimum Requirements
  • Bachelor's Degree in Engineering, or equivalent work experience.
  • Minimum of 3 years of process engineering, manufacturing engineering, or other related experience.

Required Knowledge, Skills and Abilities
  • Experience with developing and optimizing new manufacturing processes.
  • Experience with introducing new equipment / processes into production.
  • Strong problem solving / troubleshooting skills.
  • Experience with process control & statistical analysis techniques.
  • Excellent communication skills with the ability to present technical information and prepare written reports.
  • Able to work in a cross functional team environment.
  • Strong computer skills including MS Office Suite (Word, Excel, etc.).
  • Project management experience is preferred.
  • Experience in a medical device environment or other regulated industry is preferred.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

#LI-DV1

We look forward to receiving your application!

Merrimack, New Hampshire

Getinge Infection Control

Getinge Infection Control (GETINGE) is one out of three business areas within Getinge AB, a publicly-listed, Swedish-based group of companies. The Getinge Infection Control business area consists of two divisions; Healthcare and Life Science. For the Healthcare sector, GETINGE provides solutions for infection control whereas for the Life Science sector, GETINGE is a key provider of solutions for contamination prevention.

Worldwide, GETINGE ranks among the leading providers of disinfectors and sterilizers within the healthcare and life sciences segments. Since its foundation in 1904, Getinge Infection Control has stood for innovation and technological progress in the field of disinfection and sterilization. Together with the other two business areas, Extended Care (ARJOHUNTLEIGH) and Medical Systems (MAQUET), the entire Getinge Group focuses on state-of-the-art medical technology.

The Getinge Infection Control organization is to be found all over the world, with 36 subsidiaries on six continents and over 230 distributors and partner companies in sales and service representing Getinge Infection Control.

Similar jobs