Senior Design Engineer

Talent Reel; Caledonia (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Aspen Surgical in Caledonia, MI is seeking a Sr Design Engineer to design and develop medical devices, ensuring regulatory compliance and cost efficiency. You will lead design history files, perform data analysis, and collaborate with manufacturing, quality, and clinical teams to translate requirements into robust product solutions.

This on-site role includes travel up to 15% and interaction with global teams.

Qualifications

• Bachelor's degree in engineering or closely related field.
• 7+ years of medical device engineering experience preferred.
• Experience with regulatory frameworks and design controls.

Responsibilities

• Design and develop medical devices with a focus on safety, reliability, and cost effectiveness.
• Execute design history file activities to meet regulatory requirements.
• Collaborate with cross-functional teams to drive product development timelines.
• Provide technical guidance to manufacturing and quality functions.
• Assess proposed design changes and implement through cross-functional teams.
• Ensure product changes comply with regulatory and customer requirements.
• Troubleshoot design issues and perform data analysis.
• Work with portfolio managers and finance on cost considerations.

Skills

Medical device engineering

Project management

Regulatory knowledge

SolidWorks

FMEA

Communication skills

Team collaboration

Education

Bachelor of Science in Engineering

Tools

SolidWorks

Minitab

TOPS

Excel

Job description

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
• 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.
• 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