Senior Manufacturing Engineer

Resonetics; Blaine (MN); On-site; USD 88,000 - 105,000; Full time

Job summary

An established industry player in medical device manufacturing is seeking a Senior Manufacturing Engineer. This role involves managing production development for Class 2 and 3 medical devices, focusing on innovation and process improvement. You will work in a dynamic environment, collaborating with cross-functional teams to enhance product quality and efficiency. If you thrive in fast-paced settings and are passionate about engineering solutions, this opportunity is perfect for you. Join a forward-thinking company that values excellence and continuous improvement in shaping the future of micro-manufacturing.

Qualifications

• 6+ years experience in medical device manufacturing.
• Strong analytical skills for interpreting operational data.
• Proficient in NPI and PDP practices.

Responsibilities

• Manage new and existing medical device programs.
• Design and develop manufacturing processes and tooling.
• Drive process validation and documentation.

Skills

Biomedical Engineering

Mechanical Engineering

NPI Practices

Statistical Analysis

Project Management

Problem-Solving Methodologies

Education

BSc or MSc in Biomedical or Mechanical Engineering

MS in Science or Engineering (Preferred)

Tools

SolidWorks

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Senior Manufacturing Engineer will be responsible for managing the production development and readiness activities for finished medical devices and catheter sub-assemblies. This individual will act as a core team member in New Product Introduction (NPI), representing manufacturing engineering and operations. The focus will be on Class 2 and 3 medical device assemblies in the interventional space, covering various therapies and technologies. Responsibilities include managing process development, continuous improvement projects, and transferring new products and processes from multi-site Agile & LightSpeed Lab teams.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Manage new and existing medical device programs, including maintaining development/build schedules, technical customer interface, and collaboration with Resonetics Business.
• Coordinate with Development Managers and other Resonetics sites for production alignment.
• Design and develop manufacturing processes, tooling, and fixtures to meet customer demand while ensuring product quality, process efficiency, and operator safety.
• Provide production line support, including implementing process improvements, troubleshooting equipment, training staff, and addressing operator inquiries. Generate and update manufacturing process documentation following established policies and procedures per Resonetics Quality Management System.
• Utilize process improvement techniques to solve technical problems and recommend scale-appropriate equipment and processes.
• Prepare engineering reports and communicate results to internal (corporate) and external (customer) stakeholders.
• Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment Commissioning, Preventive Maintenance, etc.).

Required Qualifications

• BSc or MSc in Biomedical or Mechanical Engineering, or relevant experience.
• Minimum of 6 years experience in medical device manufacturing, designing and producing Class 2 or 3 devices.
• Proficient in NPI and PDP practices, with a demonstrated strong work ethic and deadline management skills.
• Experience solving advanced technical problems with engineering rigor and discipline. Strong analytical skills to interpret operational or technical data into business insights.
• Strong statistical analysis skills (process capability, equivalence studies, regression, ANOVA, DOE).
• Proficient in SolidWorks or equivalent for tooling/fixture design, with good GD&T and print generation skills.
• Training or experience in formal problem-solving methodologies (A3, Six Sigma, 5 Why's, DMAIC, etc.).
• Excellent report writing skills, capable of producing detailed reports, procedures, and validation protocols.
• Ability to manage tasks clearly in a fast-paced, cross-functional environment.
• Strong project management, planning, and leadership abilities.
• Effective communication skills, comfortable leading and updating teams, customers, and leadership.

Preferred Qualifications

• MS in Science or Engineering.
• Experience with interventional device design, assembly, packaging, and sterilization.
• Leadership experience in multi-disciplinary core teams for medical devices.
• Certification or training in Lean Six Sigma.
• Knowledge of ISO 13485 and QMS standards.
• Project Management Professional (PMP) certification.

Compensation

The compensation for this role is competitive, based on experience and qualifications, with an anticipated range of $88,000 - $105,000.