Product Engineer

Caerus Corp • Blaine, MN

17d • Onsite

About The Position

OrthoCor Medical, a business unit of Caerus Corp, is seeking a Product Engineer to support commercial products and contribute to new product design and development. The position is based on-site in Blaine, Minnesota; relocation assistance is not available.

The role focuses approximately 60% on continuation engineering and 40% on new product design. The engineer will own the technical health, reliability, manufacturability, and continuous improvement of released products, investigating problems and implementing corrective actions. They will also collaborate on designing and testing new products and iterations, representing mechanical and electromechanical engineering and applying lessons learned from existing products.

The Product Engineer works cross-functionally with Quality, Regulatory, manufacturing, suppliers, and other stakeholders. The role includes engineering changes, product investigations, production support, supplier and component evaluations, design transfer, mechanical design, prototyping, testing, and engineering documentation in support of quality and regulatory requirements. The company develops wearable devices for drug-free pain management that combine mechanical components, soft goods, and electronic subsystems.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering or technical discipline.
• 5+ years of progressive engineering experience in product development, sustaining engineering, quality engineering, manufacturing engineering, or a related engineering function.
• Experience working with regulated products; medical device experience is highly preferred.
• Experience applying engineering principles and professional judgment to evaluate technical problems, develop solutions, and make recommendations.
• Experience working within structured product development and change processes, including design controls, change control, and technical documentation.
• Experience with design controls, engineering change control, CAPA, complaints, nonconformances, and product failure investigations.
• Experience with mechanical design and CAD.
• Strong root-cause analysis, problem-solving, analytical, and technical decision-making skills.
• Experience developing or implementing verification and reliability testing and test methods.
• Ability to analyze technical data, identify risks and trends, and develop sound engineering recommendations.
• Strong written and verbal communication skills, including communicating technical information, risks, recommendations, and project status to technical and non-technical stakeholders.
• Strong organizational skills and attention to detail, with the ability to manage multiple projects and competing priorities.

Nice To Haves

• Experience with SolidWorks or similar 3D CAD software.
• Hands-on experience with prototyping, 3D printing, and/or soft goods or wearable product development.
• Experience with electromechanical assemblies, including connectors, cable routing, and strain relief, and collaboration with electrical or firmware engineers.
• Experience in a medical device environment, including familiarity with FDA requirements, ISO 13485, verification and validation, and design transfer.

Responsibilities

• Lead continuous improvement of released products, focusing on quality, reliability, functionality, manufacturability, and cost.
• Own engineering changes, including technical assessments, testing, documentation, and implementation.
• Investigate product failures, complaints, manufacturing issues, and supplier concerns to identify root causes and drive corrective actions.
• Analyze product performance and failure trends to identify risks and opportunities for improvement.
• Partner with Quality and Regulatory on CAPA investigations and engineering-related corrective actions.
• Provide engineering support for production issues, design-related defects, process variation, and component concerns.
• Evaluate supplier, material, and component changes to determine appropriate testing and qualification requirements.
• Support design transfer and collaborate cross-functionally to ensure products can be manufactured consistently and efficiently.
• Contribute to new product development and design improvements through concept evaluation, risk assessment, prototyping, testing, and manufacturability reviews.
• Develop mechanical designs, specifications, CAD models, and prototypes using applicable design tools.
• Maintain engineering documentation and support verification activities to meet quality and regulatory requirements.

Benefits

• Annual bonus program eligibility; opportunities are based on company and subject to the applicable bonus plan.
• Health, dental, vision, basic life, and AD&D insurance.
• 401(k) retirement plan with employer match.
• Paid time off, including vacation and protected paid time, and six company-designated holidays.
• Tuition Assistance Program.
• Employee Brace Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level