Senior Manufacturing Engineer

Job Title:

Advanced Manufacturing Engineer

Leading Medical Device Organization hiring - Engineering & Manufacturing Facility located in Lafayette, CO

Job Description:

This Advanced Manufacturing Engineer role focuses on advanced manufacturing engineering for electrosurgical electronic hardware within a regulated medical device environment. You will support design changes and manufacturing implementation by leading process validation activities, test method validation, and manufacturing system integration. The position requires close collaboration with a Lead Manufacturing Engineer and cross-functional teams to ensure robust, compliant, and efficient manufacturing processes.

This is a highly visible, fully onsite role that offers strong exposure to design change implementation, process validation, and ownership of PLM and ERP/MRP systems.

Work Environment:

+ This role is based 100% onsite at a manufacturing and engineering facility dedicated to regulated medical device production.

+ The position involves close, daily collaboration with Manufacturing, Quality, and Design Engineering teams, providing regular interaction across functions and disciplines.

+ The workweek is structured around a stable 40-hour schedule with clearly defined project scopes, offering a balanced and predictable workload.

+ You will work with advanced manufacturing technologies, electronic hardware, and integrated PLM, ERP, and MRP systems to support production and continuous improvement in a highly regulated, safety-conscious setting.

Technical

Qualifications:

+ 5+ years in manufacturing engineering

+ Direct experience leading and executing process validation activities, including IQ/OQ/PQ, for manufacturing processes.

+ Performing test method validation for hardware test systems, including software-enabled test equipment.

+ Proficiency in process validation methodologies and documentation within a regulated environment.

+ Hands-on experience using PLM, ERP and MRP systems in a manufacturing environment.

Responsibilities:

+ Lead and execute process validation activities (IQ/OQ/PQ) to qualify new or modified manufacturing processes that support electronic medical devices.

+ Develop, author, and execute validation protocols and reports to ensure manufacturing processes meet regulatory and internal quality requirements.

+ Plan and perform test method validation for hardware test systems, including software-enabled test equipment, to ensure repeatability, reliability, and compliance.

+ Conduct gage R&R studies and other measurement system analyses to verify the suitability and capability of measurement tools and methods.

+ Own and manage bills of materials (BOMs) within product lifecycle management (PLM) systems, ensuring accurate configuration, revision control, and traceability.

+ Integrate components and configurations into enterprise resource planning (ERP) and material requirements planning (MRP) systems to support manufacturing and service operations.

+ Collaborate closely with Manufacturing, Quality, and Design Engineering teams to implement design changes into production while maintaining product quality and compliance.

+ Provide hands-on engineering support to production teams, troubleshooting issues, optimizing processes, and ensuring smooth manufacturing execution.

+ Partner with quality teams to ensure validation activities, documentation, and manufacturing processes comply with applicable regulations and internal procedures.

+ Support continuous improvement initiatives within the manufacturing environment to enhance process robustness, efficiency, and product quality.

+ Communicate project status, risks, and mitigation plans to stakeholders, maintaining clear documentation throughout the product and process lifecycle.

Job Type & Location

This is a Contract position based out of Lafayette, CO.

Pay and Benefits

The pay range for this position is $50.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision  - Critical Illness, Accident, and Hospital  - 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)

Workplace Type

This is a fully onsite position in Lafayette,CO.

Final date to receive applications

This position is anticipated to close on Jun 15, 2026.

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