Sr Design Engineer

Talent Acquisition Team • Caledonia, MI

129d • Onsite

About The Position

The Sr Design Engineer designs medical devices to support the growth, cost profile, and business continuity of Aspen Surgical products in a collaborative team environment. The role supports global revenue growth and margin improvement projects, organic growth functions related to acquisitions and business migrations, and sustaining engineering that maintains business continuity.

The engineer develops and evaluates medical device designs against defined product requirements, optimizing for safe clinical solutions, production, reliability, and cost effectiveness. The position executes design history file activities in accordance with applicable regulations; evaluates and implements product changes; troubleshoots design issues; and conducts engineering and data analyses. It also provides technical assistance to other departments and supports compliance with regulatory requirements and internal and external customer needs.

The role manages project schedules, budgets, risks, tasks, and deadlines, and communicates plans and progress, including to leaders. It collaborates globally with portfolio managers, clinicians, manufacturing, finance, vendors, manufacturing facilities, and internal teams to understand product impacts, guide design direction, ensure safe and quality production, develop product costing, and resolve design and manufacturing issues. The engineer also provides peer mentoring and guidance. The position is based onsite in Caledonia, Michigan, with 15% expected travel.

Requirements

• Bachelor of Science degree in Engineering or a closely related four-year technical degree.
• Regulated-industry experience, including applicable requirements such as FDA 21 CFR 820.30, ISO 13485, ISO 14971, MDSAP, and European MDD/MDR.
• Working knowledge of ISO 11607 regulations and transit testing to ASTM 4169 or similar standards.
• Strong familiarity with risk management methods and Failure Mode Effects Analysis (FMEA).
• Working knowledge of design history and technical files in an auditing environment.
• Working knowledge of statistical data analysis used to meet or define design criteria.
• Project management experience managing and completing multiple projects simultaneously.
• Experience with business case development for product costing as it relates to design.
• Teamwork, effective communication, and a positive attitude.
• Ability to manage global interactions and collaborations while addressing cultural differences.
• Clinical safety and quality-first mindset.
• Initiative and proactive risk mitigation.
• Commitment to continuing education to advance medical device design and development knowledge.
• Excellent computer skills, including Microsoft Office Suite.

Nice To Haves

• Seven or more years of medical device engineering experience.
• PMP certification.
• Experience with IEC 60601 and/or IEC 62304.
• Involvement with invention disclosures or patents.
• Experience using engineering programs such as SolidWorks, Minitab, TOPS, or similar.

Responsibilities

• Support design tasks for global revenue growth and margin improvement projects.
• Support organic growth functions related to acquisitions and other business migrations.
• Support sustaining engineering functions to maintain business continuity.
• Execute medical device design history file activities in compliance with applicable regulations.
• Develop and evaluate medical device designs that meet defined requirements and are optimized for clinical safety, production, reliability, and cost effectiveness.
• Provide technical assistance to departments and individuals exploring new opportunities.
• Evaluate proposed changes to existing products and complete deliverables needed to implement changes, independently or through cross-functional teams.
• Ensure product changes comply with regulations and internal and external customer requirements.
• Troubleshoot product design problems and conduct engineering and data analyses.
• Manage project schedules, budgets, risks, and issues; recommend and communicate project plans, track tasks, and manage time to meet deadlines.
• Communicate project matters clearly and efficiently to leaders.
• Work with portfolio managers to understand clinical and commercial impacts.
• Communicate design concepts to clinicians to obtain design direction.
• Work with manufacturing throughout development to support safe, efficacious, and quality production within established time frames.
• Work with finance to develop product costing and understand the effects of material and design selections.
• Interface with vendors, manufacturing facilities, and internal groups to resolve design and manufacturing issues for new and existing products.
• Provide peer mentoring and guidance to other engineers across the company.

What This Job Offers

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