R&D Engineer

This role focuses on developing, validating, and improving manufacturing processes for medical devices in a research and development setting.

Responsibilities

• Author and execute process validations, including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).
• Define specifications for process development equipment and lead the acquisition and implementation of new equipment to support manufacturing processes.
• Apply engineering principles, theories, concepts, practices, and techniques to analyze and solve process-related problems in a medical device environment.
• Design and conduct experiments, complete validation testing, and perform data analysis to support continuous improvement activities.
• Prepare and present data, findings, and recommendations to equipment teams and other stakeholders to support decision-making and process optimization.
• Evaluate current equipment for process suitability and develop detailed plans for improvement in quality, efficiency, and safety.
• Create and revise manufacturing documents, including specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documents to maintain compliant and efficient processes.
• Collaborate with other engineers and technicians to develop solutions and improvements in materials, equipment, and processes as needed.
• Participate in cross-functional teams to drive continual improvement, safety, and regulatory compliance in manufacturing operations.
• Provide training and process expertise for product processing in specific areas such as process development, tooling development, and validation.
• Interact cross-functionally and communicate effectively with internal and external customers to support process development and validation activities.

Requirements

• 1–3 years of experience in process development or a related engineering role, preferably within the medical device industry.
• Hands-on experience in medical device manufacturing or development environments.
• Proficiency in authoring and executing process validations, including TMV, IMV, IQ, OQ, PQ, and PPQ.
• Strong understanding of engineering principles, theories, concepts, practices, and techniques relevant to process development.
• Ability to analyze and solve problems using basic engineering principles and data-driven approaches.
• Experience designing experiments, conducting validation testing, and analyzing data to support continuous improvement.
• Capability to create, revise, and maintain technical manufacturing documentation such as SOPs, specifications, safety instructions, validation protocols, and risk assessments.
• Effective collaboration skills to work with engineers, technicians, and cross-functional teams.
• Clear communication skills to present data and interact with internal and external customers.

Qualifications

• Bachelor's degree in engineering or a related technical field is preferred.
• Experience supporting continual improvement initiatives in manufacturing or R&D environments.
• Familiarity with process development and tooling development in a regulated industry.
• Ability to provide training and guidance on process and validation activities.
• Comfort working with validation and qualification frameworks in medical device or similarly regulated sectors.

Work Environment

The role operates within a medical device development and manufacturing environment that emphasizes safety, compliance, and continuous improvement. Work involves close collaboration with equipment teams, engineers, technicians, and cross-functional stakeholders, including internal and external customers. The position is hands-on and requires regular interaction with process development equipment, validation activities, and technical documentation to support efficient and compliant operations.

Pay

The pay range for this position is $37.00 - $38.00 per hour. Individual compensation offered within this range will depend on factors such as qualifications, skills, relevant experience, job knowledge, geographic location, and internal equity.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)

Schedule

This is a fully onsite, contract position based in Minnetonka, MN.