Develops new manufacturing processes using prototyping, characterization and validation methods.

Develops manufacturing and inspection fixturing and equipment for new processes.

Assists in new equipment/tooling identification, procurement, installation qualification, document creation and training.

Provides technical expertise in risk identification and responses to enable capable and robust product realization.

Uses statistical tools to analyze data, drive decisions, reduce risk and improve manufacturing processes (Six Sigma, SPC, DOE, Cpk).

Supports cross-functional teams to transfer manufacturing processes to production and enable high volume ramp-up.

Creates and maintains validation documentation to successfully introduce new products into manufacturing.

Assumes responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, create documentation, train) including ownership of process capability, process quality and process costs.

Supports continuous processes improvement identification and implementation in accordance with site priorities to improve efficiency, quality, reduce costs and meet market technology needs.

Maintains knowledge of new and developing manufacturing technologies and applies knowledge to recommend and implement new manufacturing processes.

Utilizes IT tools for efficient execution of duties.

Develops or revises procedures, work instructions and other documents as required.

Performs other duties and responsibilities as assigned.

Bachelor’s degree in Mechanical Engineering or equivalent work experience required.

A minimum of 3 years’ experience as a Manufacturing Engineer required.

Excellent time management skills with a proven ability to meet deadlines.

Strong analytical and problem-solving skills with the ability to assess problems or issues with manufacturing equipment.

Extensive knowledge of production principles and techniques.

Proficient with Microsoft Office Suite and computer-aided drafting (CAD) software.

Working knowledge of medical device standards and regulations or an ability to developing a working knowledge of standards and regulations required.

Must possess strong verbal and written communication skills with the ability to communicate with colleagues of various cultures and personalities and across internal and external teams.

The right candidate will have an analytical mindset, strong attention to detail and be able to work independently.