Job Description

Role: ​Manufacturing Engineer

Location: Minnetonka, MN - 55345

- 100% Onsite role

- 10% travel involved to Puerto Rico (Once or twice in a quarter)

- Strictly Local candidates only

​Skills Looking For:

• Manufacturing Engineer.
• Transfer existing manufacturing line to Puerto Rico; Deport/transfer catheter manufacturing line to Puerto Rico.
• ​T​he main responsibilities will be Operational Qualification assessments to support validating critical operators.
• Knowledge and capability to perform IQ, OQ, PQ, test method validations, ​and Process categorizations.
• Writing and executing protocols
• Writing reports and doing analysis.
• ​C​conducting process equipment installation, operational performance qualification.
• ​Ability to apply process; Process performance Qualification.D
• oing some time studies. Analyzing the process in the current state and also in Puerto Rico as ​the transition takes place.S
• oftware systems: Timer Pro.A
• ny experience with SAP, Office ​T​timeline Pro, Windchill, Power BI will be plus.D
• igitizing documents; Design History Records or Batch records; going from paperwork to digital.M
• edical device experience is strongly preferred. Open to ​the aerospace industry as well.​

Education and Experience​

• B​bachelor's degree (Engineering degree - Mechanical, Manufacturing, Industrial, Bio-Medical)M
• inimum 4 to 5 years of relevant experience is required.A
• nything over 10​ years of experience will be over-qualified for this role.​

Top SkillsI

• Q, OQ, PQ, TMQ, TQF experience.W
• rite and execute protocols; Writing reports etc.C
• ritical thinking; Ability to execute according to timeline​

Interview Process:V

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