Senior Medical Device Design Engineer

Colonial Group; Caledonia (MI); On-site; USD 110,000 - 140,000; Full time

Job summary

Aspen Surgical is seeking a Senior Design Engineer to lead medical device design activities, ensuring regulatory compliance and cost-effective solutions. You will partner with clinical, manufacturing, and finance teams to drive robust product development and continuous improvement.

The role requires deep experience in regulated medical devices, strong communication, and collaboration across global teams, with 15% travel and on-site work in Caledonia, MI.

Qualifications

• Bachelor of Science in Engineering or closely related 4-year technical degree.
• 7+ years medical device engineering experience preferred.
• PMP certification preferred.
• FDA 21 CFR 820.30, ISO 13485, ISO 14971, MDSAP and EU MDR experience.
• ISO 11607 knowledge and transit testing per ASTM 4169.
• IEC 60601 and IEC 62304 knowledge preferred.
• Knowledge of Risk Management and FMEA.
• Design history file knowledge and auditing experience.
• Statistical analysis knowledge.
• Project management across multiple projects.
• Involvement with invention disclosures or patents.
• Product costing related to design decisions.
• SolidWorks, Minitab, TOPS experience.
• Teamwork, communication, and global collaboration.
• On site in Caledonia, MI with 15% travel.

Responsibilities

• Execute medical device design history file activities to meet regulatory requirements.
• Develop and evaluate designs optimized for safety, production, reliability, and cost.
• Provide technical support across departments for new opportunities.
• Evaluate changes to existing products and implement them via cross-functional teams.
• Ensure changes meet regulatory and customer requirements.
• Troubleshoot and solve design issues; perform thorough data analysis.
• Manage project schedules, budgets, risks, and timelines.
• Communicate project plans and progress to leadership.
• Collaborate with portfolio managers on clinical and commercial impact.
• Coordinate with manufacturing to ensure safe, efficacious production within timeframes.
• Interface with finance on product costing implications.
• Mentor peers and guide engineers across the company.

Skills

Project management

Communication

Teamwork

Mentoring

Risk assessment

Education

Bachelor of Science in Engineering

Tools

SolidWorks

Minitab

TOPS

Job description

Aspen Surgical is seeking a Senior Design Engineer to lead medical device design activities, ensuring regulatory compliance and cost-effective solutions. You will partner with clinical, manufacturing, and finance teams to drive robust product development and continuous improvement.

The role requires deep experience in regulated medical devices, strong communication, and collaboration across global teams, with 15% travel and on-site work in Caledonia, MI.