Senior/Principal Manufacturing Engineer

ZipRecruiter; Minneapolis (MN); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled process and manufacturing development engineer to enhance their innovative medical device offerings. This role involves collaborating with contract manufacturers to ensure product quality and adherence to regulatory standards. You will manage validation plans, develop manufacturing procedures, and provide technical expertise in new process development. Join a forward-thinking company that values continuous improvement and offers a comprehensive benefits program, including unlimited paid time off and a 401(k) plan with matching. If you are passionate about making a difference in the medical device industry, this opportunity is perfect for you.

Benefits

Medical, dental, and vision plans

401(k) plan with company matching

Unlimited Paid Time Off (PTO)

Approximately 15 paid company holidays

Qualifications

• 5+ years of relevant experience in engineering roles within the medical device industry.
• Proficiency with Microsoft Office and statistical software like Minitab.

Responsibilities

• Oversee contract manufacturers to ensure product availability and business continuity.
• Manage product manufacturing and process validation technical support.

Skills

Engineering experience in medical device industry

Vendor management

Continuous improvement methodologies (Six Sigma, Lean)

Technical report preparation

Statistical analysis

Education

Bachelor’s Degree

Tools

Microsoft Office Suite

Minitab

Smartsheet

Solidworks

Job description

Job Description

MicroTransponder Inc. has developed the Paired Vagus Nerve Stimulation Platform (Paired VNS Platform), based on decades of neuroscience research. The Vivistim System, for improving stroke survivors' hand and arm function, is the first FDA-approved system on the platform.

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.

Key Responsibilities

• 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.

Requirements

• 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.

Benefits

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.