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Posted Monday, July 10, 2023
Posting ID: JP-003894205
Actalent Services is seeking to add a Manufacturing Engineer onsite with our team in SLC, Utah!
Looking for a Expert Level Manufacturing Engineer to support the Design & Development group in ensuring devices, components, and materials in development comply with SOP's and applicable regulatory standards. This will consist of Injection Molding Materials, Catheters, Oscilloscopes, Capital Equipment, Extrusions, etc.
This person will need to have the ability to be flexible and interact with customers as well as internal stakeholders to ensure the production on the floor is a success. 70% of this persons work will be auditing projects and processes and making sure the company is in compliance.
Bachelor's Degree in Engineering or related science discipline
Engineering experience with a Medical Device company
Knowledge of Design Controls (FDA 21 CFR 820.30)
Experience with design, process, and test method validations (DV, IQ, OQ, PQ, TMV)
Experience with Risk Management (Risk Management Plans, FMEA's) and associated standards (ISO 14971:2019)
Familiar with Quality Management Systems (FDA 21 CFR 820 and ISO 13485:2016)
Experience working in cross-functional teams and driving projects to completion
NICE TO HAVE SKILLS:
Strong communication, presentation, and project management skills
Root cause analysis
Statistical Analysis (Six Sigma preferred)
Microsoft Office and Minitab Statistical Analysis software (or equivalent)
Ability to develop effective, positive interpersonal relationships, and lead a cross-functional team.
Effectively employ problem-solving tools/methodology
High sense of urgency and commitment to execution
Driven, energetic, self-assured professional with high personal integrity
Manage projects and provide project support from the Quality function
Interact effectively with customers, suppliers, and internal resources
Risk Management, identify risks and develop mitigation actions
Lead or support design and process validations (DV, IQ, OQ, PQ)
Quality System maintenance and improvement
CAPA ownership and/or support
To be in consideration for the role described above, please submit an updated resume here!
Recruiter: Brooke Carlson