R&D Engineer

Spectraforce Technologies, Inc.; Minnetonka (MN); On-site; USD 75,000 - 115,000; Part time

Job summary

Spectraforce Technologies, Inc. is seeking an R&D Engineer in Minnetonka, MN to advance medical device processes through validation and rigorous engineering practices.

You will author SOPs, design experiments, analyze data and collaborate across teams to improve quality, efficiency and compliance in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree preferred, 1-3 years experience in medical device engineering.
• Experience with Process Validations including TMV, IMV, IQ, OQ, PQ, PPQ.
• Develops and validates manufacturing processes and associated documentation.

Responsibilities

• Author and execute Process Validations (TMV, IMV, IQ, OQ, PQ, PPQ).
• Responsible for process development, equipment specification, acquisition and implementation.
• Creates and revises manufacturing SOPs, risk assessments and validation protocols.
• Interacts cross-functionally with internal and external customers to ensure compliance and quality.
• Presents data to equipment teams and supports continual improvement.

Skills

Process validation experience

Data analysis

Cross-functional collaboration

Education

Bachelor's degree

Job description

Position Title: R&D Engineer

Work Location: Minnetonka MN

Assignment Duration: 5+ Months

• 1-3 years experience
• Preferred education: Bachelor's degree
• Required experience: Medical device
• 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.