Sr. Principal Mechanical Process Development Engineer (Northridge, Ca)

Careers That Change Lives 

As a member of the Mechanical Engineering R&D group, the individual selected for this role will lead new product design activities of products such as insulin pumps, glucose sensors, and related accessories.  They will work at the intersection of product design and Process Development, optimizing for customer and business needs.

The ideal candidate for this position has had extensive experience in new product and Process Development, design, verification, and validation.  Experience in plastics and electromechanical assemblies in the medical device industry a plus.  The ideal candidate has a strong background in process design, development and qualification including Test Method Validation (TMV) as well as hands-on prototyping/testing.  This individual is experienced in problem solving and performing data analysis using statistical methods and tools (DOE, Regression, ANOVA, Capability Analysis, GR&R).  Self-Starter and a technical leader with a sharp focus on quality and customer experience.  This position will work across the organization driving and collaborating with functions in R&D, Operations, PMO, Quality and Regulatory to assure the successful execution of business goals.

We are a learning culture.  An inventive and collaborative group.  We are dedicated to making sure that every patient gets the best product - when they need it.  We have strong ties to our local communities.  Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare. #ReferMDTDiabetes  

Job duties to be primarily located on-site in Northridge, CA with the ability to work limited hours remotely.

A Day in the Life

• Drive and lead product and Process Development activities of complex medical products by identifying key process inputs, outputs, controls, and noise factors by effective utilization of Six Sigma tools

• Drive and lead design transfer activities ensuring product is transitioned to manufacturing facility successfully

• Apply methodologies such as Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly / Automation (DFM/A) during process design and development phase

• Lead and perform process characterization, design verification / testing, and Test Method Validation (TMV) activities
• Apply Six Sigma (DFSS) methodologies to all aspects of the design / development process

• Perform Statistical analysis (DOE, Regression, ANOVA, Capability Analysis, GR&R)

• Help with equipment selection, tooling and fixture development, procurement, installation, and qualification.

• Drive corrective and preventive actions with appropriate and detailed follow up

• Provide guidance and mentorship to junior engineering staff

• Help develop specifications, test methodologies, and test equipment to evaluate design concepts

• Perform calculations, analyses, and engineering testing to verify the designs and design changes. Document results in engineering reports and laboratory notebooks

• Works closely with strategic partners and vendors to support current products and initiate new production projects and assists in developing processes/techniques to meet contract objectives

• Help ensure designs meet and exceed product specifications, regulatory requirements, and international standards

• Design / develop components to be manufactured via plastic injection molding, stamping, machining, extrusion, and related processes

• Work with manufacturing to ensure feasibility of high-volume assembly in early phase of development cycle 

• Translate voice of customer (VOC) feedback into engineering requirements

• Work with suppliers to ensure components meet design requirements & diagnose design / process problems

• Present technical findings or project status to cross functional teams and management through meeting minutes, design reviews, presentations, and other means of communication. 

• Travel to supplier and manufacturing sites as required