Engineer II, Product Sustaining
- Write and execute protocols, such as Design Validations or Verifications. Compile, analyze and report protocol test data.
- Write and execute Test Method Validations. Compile, analyze and report testing data.
- Update Design Specifications, Risk Management Plans and Reports, FMEAs, or other risk management documents.
- Investigate and plan CAPA activities
- Communicate and Coordinate activities with other Getinge sites and outside component suppliers.
- Implement documentation changes as needed. (Engineering specifications, change notices, manufacturing procedures, and other documentation).
- Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
- Develop processes, methods, tooling, and production controls; supervises their assembly and proofing.
- Prepares presentations reflecting the status and results of projects.
- Lead small projects that support product enhancement and cost savings opportunities.
- This is not an inclusive list of job responsibilities.
- Bachelor of Science degree (or equivalent), preferably in Biomedical, Mechanical or Manufacturing Engineering with 3-6 years of related experience.
- General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
- Experience with process and equipment validations/qualifications.
- Experienced with laboratory physical testing methods Validation/Verification
- Process Validation/Verification
- Knowledge with the following systems: CAPA, Risk Management, Design Controls and Change Management
- Must have strong technical and analytical ability; detail oriented.
- Must have good verbal and written communication skills.
- Strong interpersonal skills.
- Good organizational skills. Must be able to adhere to timelines.
- Knowledge of computer skills including, but not limited to: Microsoft Windows, Word, Excel, Project, PowerPoint, Teams, Solidworks
- Basic understanding of statistical analysis.
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
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