R&D Engineer

Spectraforce Technologies; Minnetonka (MN); On-site; USD 60,000 - 90,000; Full time

Job summary

Spectraforce Technologies is seeking an R&D Engineer for a 6-month engagement in Minnetonka, MN. The role focuses on process validation, equipment specification, and continual improvement of manufacturing methods for medical devices.

Ideal candidates hold a Bachelor's degree in Engineering and have 1–3 years of medical device experience, with strong data analysis, documentation, and cross-functional collaboration skills.

Qualifications

• Experience in validation of medical devices and processes.
• Strong ability to analyze data and translate results into improvements.
• Experience creating and revising SOPs, risk assessments, and validation protocols.

Responsibilities

• Author and execute process validations including TMV, IMV, IQ/OQ/PQ/PPQ.
• Develop and implement process improvements, equipment specs, and validations.
• Create and revise manufacturing documents, SOPs, and risk assessments.

Skills

Process Validation

TMV

IMV

IQ

OQ

PQ

PPQ

Documentation

Data Analysis

Cross-functional

Education

Bachelor's degree in Engineering

Job description

Description:

Title: R&D Engineer

Duration: 06 Months

Location: Minnetonka, MN ( 55345)



Roles and responsibilities

• Author and execute Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ)


• Responsible for process development, equipment specification, acquisition and implementation.


• Understands engineering principles theories, concepts, practices and techniques.


• Analyzes and solves problems from basic engineering principles.


• Completes design of experiments, validation, completion of testing and analysis of data for continuous improvement activities. Presents data to equipment teams.


• Suggests and supports new methods or materials for continual improvement of quality and efficiency.


• Analyzes current equipment for process suitability and provides detailed plans for improvement


• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures.


• Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary.


• Participates in teams as necessary to ensure continual improvement, safety and compliance.


• Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation.


• Interacts cross functionally and with internal and external customers.

Preferred education: Bachelor's degree

Required experience: Medical device

1-3 years experience