Manufacturing Engineer

Actalent Services is seeking to add a Manufacturing Engineer onsite with our team in SLC, Utah!

Job Description:

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.

MUST HAVES:

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

Technical writing

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

OTHER RESPONSIBILITES:

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!