Sr 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

Summary

The Sr Design Engineer is responsible for Design medical devices to support the growth, cost profile, and business continuity of Aspen Surgical products while working in a collaborative team environment.

In This Position, You Will Have the Opportunity to:

• Support design tasks associated with global revenue growth and margin improvement projects
• Support organic growth functions of acquisitions and other business migrations
• Support sustaining engineering functions of the organization to maintain business continuity

Medical Device Product Development

• Execute medical device design history file activities to be compliant with applicable regulations
• Conduct the development and evaluation of medical device designs which meet defined product requirements and that are optimized for safe clinical solutions, production, reliability, and overall cost effectiveness for the business
• Provide technical assistance to various departments and individuals as necessary in the exploration of new opportunities
• Evaluate proposed changes to existing products and complete deliverables required to implement the change through individual efforts or cross-functional teams
• Ensure that product changes meet regulations as well as internal and external customer requirements
• Troubleshoot and problem-solve efforts related to product design.
• Conduct thorough engineering and data analysis.

Project Management

• Responsible for project schedules, budgets, mitigating risks, and efficient solutioning of issues
• Recommend and communicate project plans, track tasks, and manage time to meet project deadlines
• Executive presence for communicating with leaders in a clear efficient manner

Global Collaboration

• Work closely with the portfolio managers to understand clinical and commercial impacts.
• Strong communication skills to convey design concepts to clinicians to obtain design direction
• Work with manufacturing throughout the development phases to ensure that products are produced in a safe, efficacious, and quality manner while keeping within established time frames
• Work with finance to develop product costing to understand impacts of material/design selections
• Interface with vendors, manufacturing facilities, and various internal groups to resolve design and manufacturing issues of new and existing products
• Provide peer mentoring and guidance to other engineers throughout the company

What You Need to Succeed in This Position

• Bachelor of Science Degree in Engineering or closely related 4-year technical degree is required
• 7+ years of medical device engineering experience preferred
• PMP certification preferred
• Regulated industry experience that includes, but not limited to, FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
• Working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards
• Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance Requirements) and/or IEC 62304 (Medical Device Software Lifecycle Requirements) preferred.
• Strong familiarity with the methods of Risk Management and Failure Mode Effects Analysis (FMEA)
• Working knowledge of design history & technical file within an auditing environment.
• Working knowledge of statistical analysis of data used to meet or define design criteria
• Project management experience to effectively manage and complete multiple projects simultaneously
• Involvement with invention disclosures or patents
• Business case development for product costing as it pertains to design
• Preferred experience using engineering programs such as SolidWorks, Minitab, TOPS, similar.
• Teamwork, effective communication, and positive attitude required to fit & grow culture
• Effectively handles global interactions and collaborations while managing cultural differences.
• Models clinical safety and quality first mindset
• Takes initiative and proactively mitigates risks
• Continuous education focused to advance job knowledge in medical device design & development
• Excellent computer skills including but not limited to Microsoft Office Suite
• On site job located in Caledonia, MI with 15% expected travel