Senior/Principal Manufacturing Engineer

MicroTransponder; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

MicroTransponder, a leader in neurostimulation technology, seeks a skilled professional for process and manufacturing development. This role involves collaboration with contract manufacturers and ensuring product quality and compliance. Qualified candidates should possess a relevant engineering degree and experience in the medical device sector, as they contribute to advancing rehabilitation solutions for stroke survivors.

Benefits

Medical, dental, and vision plans

401(k) plan with company matching

Unlimited Paid Time Off (PTO)

Approximately 15 paid company holidays per year

Qualifications

• Bachelor’s degree with 5+ years of relevant experience.
• Experience in medical device manufacturing and vendor management.
• Competency in Minitab and Solidworks essential.

Responsibilities

• Oversee and technically support contract manufacturers.
• Manage product manufacturing and process validation.
• Develop manufacturing procedures and validation plans.

Skills

Vendor management

Statistical process control

Continuous improvement methodologies

Proficiency in Microsoft Office Suite

Process validation

Risk assessment

Education

Bachelor’s Degree

Tools

Minitab

Solidworks

Smartsheet

Job description

MicroTransponder, Inc. is dedicated to transforming the lives of stroke survivors through its innovative neurostimulation technology. The company's flagship product, the FDA-approved Vivistim Paired VNS System, enhances stroke rehabilitation by pairing vagus nerve stimulation (VNS) with physical and occupational therapy. This approach leverages the brain's neuroplasticity to improve upper limb function, offering new hope to those with chronic arm and hand impairments following an ischemic stroke.

By integrating this therapy into rehabilitation programs, MicroTransponder aims to help stroke survivors regain independence in daily activities and enhance their quality of life. The company's commitment to advancing stroke recovery is evident in its ongoing research and collaboration with healthcare providers to make this therapy accessible to more patients.

About the role

This position is responsible for process and manufacturing development on existing commercially released products and for new products in collaboration with MTI’s contract manufacturers. This includes creating and managing master validation plans for MTI’s products. This position will work closely with quality, operations, regulatory, and external contract manufacturers to ensure products are developed and supported and adhere to design controls, applicable standards, and regulations.

What you'll do

• Oversee and technically support contract manufacturers to ensure product availability and business continuity.
• Manage and execute continuation activities for internal and contract manufacturer changes as an individual contributor.
• Manage and/or participate in product manufacturing and process validation technical support, including creating and managing Master Validation Plans.
• Develop manufacturing procedures, manufacturing travelers, and manufacturing controls in-house and in collaboration with contract manufacturers.
• Provide direction and manage contract manufacturers on manufacturing-related commercial production and product development projects.
• Provide technical expertise as required in new process development, test method validations (TMV), process characterization and analysis, and process validation (installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)) activities.
• Manage and/or participate in Design Assurance activities such as risk assessment, FMEAs, such as Process FMEA (PFMEA).
• Develop and/or advise on manufacturing processes that are applicable to statistical process control, and develop those techniques.
• Oversee the development of new processes, technologies, or tooling needed to manufacture the company’s products.
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Prepare technical reports by collecting, analyzing, and summarizing information and trends.

Qualifications

• Bachelor’s Degree and 5+ years of relevant experience in a related discipline required.
• Experience in engineering roles within the medical device industry is required.
• Experience in medical device manufacturing and vendor management required.
• Proficiency with computer operations, including Microsoft Office Suite (Word, Excel, PowerPoint, etc.)
• Competency with Minitab and/or other statistical software
• Competency with Smartsheet or other project management tools.
• Competency with Solidworks.
• Continuous improvement methodology experience, such as Six Sigma, Lean Manufacturing, DMAIC, etc. (valuable).

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use hands to reach, talk, or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently and work after hours as required by travel schedule or business issues.

The intent of this position description is to provide a representative summary of the major duties and responsibilities performed by the incumbents of this position. Incumbents may be required to perform job-related tasks other than those specifically presented in this job description. The incumbent will perform all other duties and tasks as assigned, for example, but not limited to covering for colleagues during their absence, or cross-functional work as needed.

Equal Opportunity Employer

MicroTransponder, Inc. is an equal opportunity employer. MicroTransponder, Inc. is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law.

MicroTransponder provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 15 paid company holidays per year.