iotaMotion is hiring a Senior Process Engineer.

Company Background

iotaMotion is dedicated to advancing cochlear implant surgery through innovative robotic technologies. Our mission is to enhance the precision and outcomes of cochlear implant procedures, ultimately improving the lives of individuals with hearing loss.

iotaMotion is seeking a Senior Process Engineer. This position will report to the Director of Operations and be based out of the Vadnais Heights, MN location. This individual will play a crucial role in supporting the Operations and Design teams to help with design for manufacturing assessment, set up, validate and maintain production processes and equipment, design transfer activities and maintain overall performance and quality of our devices. The ideal candidate has strong analytical, communication, problem-solving and organizational skills.

Key Responsibilities:

· Work cross-functionally with the design team to ensure downstream operations requirements are communicated and implemented as part of project plans and sustaining activities. Support all design transfer tasks and provide cross-functional collaboration early on to ensure DFM (Design for Manufacturing) is built in from the start of a project.

· Provide engineering support for design and process changes, equipment qualifications, and process verification and validation studies (IQ/OQ/PQ).

· Evaluate and develop manufacturing processes by designing and conducting research, applying knowledge of product design, fabrication, assembly, tooling, and materials, conferring with vendors, and soliciting observations from operators to optimize production.

· Identify, review, and fix deficiencies throughout the product life cycle.

· Manage contract manufacturer relationships and lead change management relating to improvement cut-ins, yield improvement projects, troubleshooting, cost reduction efforts and new product introduction.

· Aid in making improvements to existing products to increase reliability, reduce costs, and add functionality

· Design, procure, qualify and maintain fixtures, tooling and any equipment necessary to meet business needs.

· Develop and maintain SOP’s, work instructions, procedural documents, device master records and master validation plans.

· Manage projects as needed to implement changes and sustaining updates.

· Contribute to risk management content such as FMEA, PFMEA, and hazard analysis

· Participate in root cause analysis and action planning to support NCR’s (non-conforming reports) and CAPA’s (correct and preventative actions).

· Assist with supplier qualification, audits and material sourcing as needed.

· Maintain product and company reputation by adhering to company policy and complying with government regulations.

Qualifications:

· Bachelor’s degree in engineering discipline (or 5-7 years of equivalent experience).

· Strong organizational, analytical and problem-solving skills with the ability to deal with complex technical issues and develop practical solutions.

· Strong written and verbal communication skills with the ability to work effectively in a team-oriented environment.

· Proficiency in engineering software and tools related to design and data analysis (ie: SolidWorks, Tableau, Minitab, Excel, Word, Visio).

· Experience with testing and process validation.

· Experience with design for manufacturability and product lifecycle management.

· Knowledge of statistical analysis and quality control methodologies.

· Detail-oriented with a strong commitment to documentation and maintaining high quality and performance standards.

· Excellent attention to detail and accuracy.

· Basic knowledge of applicable quality, health, safety and environmental management systems.

· Self-starter with ability to function in a rapidly evolving startup environment.

· Experience working within a regulated environment.

Preferred Skills:

· Experience in Medical device manufacturing

· Experience with the ISO 13485 standard

· Experience with cleanroom setup and maintenance

· Experience with design transfer activities

· Experience with project management

Interested and qualified applicants please submit your resume and cover letter to jobs@iotamotion.com

iotaMotion is an equal opportunity employer and does not discriminate based on race, color, sex, age, disability, sexual orientation, gender, religion, marital status, or any other characteristic protected by law. We use E-Verify to confirm the identity and employment eligibility of all new hires.