MDR - Product Engineer II - Exempt

Lancesoft; Plymouth (MN); On-site; USD 75,000 - 110,000; Full time

Job summary

Lancesoft in Plymouth, MN is seeking a Product Engineer II to support cutting-edge medical device products with a focus on EUMDR. This onsite role offers hands-on engineering challenges in a dynamic team.

You will design manufacturing processes and layouts, drive process improvements, and ensure compliant operations through DMAIC and SPC methods. Strong collaboration with production and quality teams is essential to deliver reliable devices.

Qualifications

• Bachelor's degree in engineering; 2+ years experience, or advanced degree with 0 years experience.
• Nice to have operations/manufacturing experience with a desire to improve existing processes.
• Experience with problem-solving methodologies (DMAIC) and ability to lead problem-solving teams.
• Effective communication skills (written and verbal) with experience reporting to leadership.
• Experience with statistical software (JMP, Minitab).

Responsibilities

• Design manufacturing processes, procedures, and production layouts for assembly of combination products.
• Provide production support engineering for testing methods, procedures, device specs, and yield issues.
• Identify and implement improvements to reduce production scrap.
• Investigate and disposition nonconforming products.
• Inspect machinery performance and initiate corrective actions to ensure quality.
• Develop and maintain manufacturing processes using statistical process control.
• Provide guidance on design concepts and specification requirements to optimize equipment use.
• Design sequence of operations and specify procedures for product manufacture.
• Ensure processes and procedures comply with regulations.

Skills

DMAIC Methodology

Analytical thinking

Communication skills

Education

Bachelor's degree in Engineering

Tools

JMP

Minitab

Job description

Join our dynamic team in Plymouth, MN, where you will have the opportunity to work onsite in a vibrant and innovative environment. We are seeking a skilled Product Engineer II to support our cutting-edge medical device products, specifically focusing on EUMDR. If you have a passion for engineering and a keen eye for detail, this role is perfect for you!

Responsibilities

• Design manufacturing processes, procedures, and production layouts for the assembly of combination products supporting cardiovascular therapies.
• Provide production support engineering concerning testing methods, procedures, and problems;device specification and yield issues;minor redesign of devices and masks;analysis of customer returns;and optimizing device production relative to cost constraints.
• Identify and implement improvements to reduce production scrap.
• Investigate and disposition nonconforming products.
• Inspect performance of machinery, equipment, and tools to verify efficiency, and initiate corrective actions to ensure product quality.
• Develop and maintain manufacturing processes using statistical process control.
• Provide guidance regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Design sequence of operations and specify procedures for product manufacture.
• Ensure processes and procedures comply with regulations.

Requirements

• Must Have Bachelor’s degree in engineering (Mechanical, Biomedical, Chemical, or Industrial preferred) and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
• Nice to Have Operations/Manufacturing experience with a desire to improve existing processes.
• Experience with problem-solving methodologies (e.G., DMAIC) and the ability to lead problem-solving teams.
• Effective communication skills (written and verbal) with experience reporting to leadership.
• Experience with statistical software (JMP, Minitab).