Senior / Principal Manufacturing Engineer

MicroTransponder; Minneapolis (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

MicroTransponder is seeking a Process Development Engineer to oversee manufacturing and validation processes for medical devices. The role involves collaboration with contract manufacturers, managing validation plans, and ensuring compliance with industry standards. Candidates should have a Bachelor's Degree and at least 5 years of relevant experience in the medical device sector, along with proficiency in statistical software and project management tools.

Benefits

Medical, dental, and vision insurance

401(k) with match

Unlimited PTO

About 15 paid holidays annually

Qualifications

• 5+ years of relevant experience in a related discipline.
• Experience in engineering roles within the medical device industry.
• Experience with continuous improvement methodologies preferred.

Responsibilities

• Oversee and support contract manufacturers to ensure product availability.
• Manage and execute continuation activities for internal and contract manufacturer changes.
• Develop manufacturing procedures and controls in collaboration with contract manufacturers.

Skills

Project Management

Statistical Process Control

Process Development

Validation Activities

Continuous Improvement

Education

Bachelor's Degree

Tools

Microsoft Office Suite

Minitab

SolidWorks

Smartsheet

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. The role involves working closely with quality, operations, regulatory, and external contract manufacturers to ensure products are developed and supported according to design controls, standards, and regulations.

Responsibilities

1. Oversee and support contract manufacturers to ensure product availability and business continuity.
2. Manage and execute continuation activities for internal and contract manufacturer changes.
3. Support product manufacturing and process validation activities, including creating and managing Master Validation Plans.
4. Develop manufacturing procedures, travelers, and controls in collaboration with contract manufacturers.
5. Provide direction to contract manufacturers on manufacturing-related projects.
6. Offer technical expertise in process development, test method validations, process characterization, and validation activities.
7. Participate in Design Assurance activities such as risk assessments and FMEAs.
8. Advise on manufacturing processes applicable to statistical process control techniques.
9. Oversee development of new processes, technologies, or tooling.
10. Guide engineering on design concepts and specifications to optimize manufacturing.
11. Prepare technical reports by analyzing and summarizing data and trends.

Requirements

• Bachelor's Degree and 5+ years of relevant experience in a related discipline.
• Experience in engineering roles within the medical device industry.
• Experience in medical device manufacturing and vendor management.
• Proficiency with Microsoft Office Suite.
• Competency with Minitab or other statistical software.
• Experience with project management tools like Smartsheet.
• Proficiency with SolidWorks.
• Experience with continuous improvement methodologies such as Six Sigma or Lean Manufacturing (preferred).

Physical requirements include standing, walking, sitting, manual dexterity, and occasional lifting up to 20 pounds. Travel by car or airplane is expected, and work hours may extend as needed.

The position may require performing additional tasks beyond those listed, including cross-functional work or covering colleagues.

Benefits

MicroTransponder offers comprehensive benefits including medical, dental, vision, FSA, 401(k) with match, unlimited PTO, and about 15 paid holidays annually.