About this opportunity
Colonial Group lists this Sr Design Engineer opportunity in caledonia, Michigan. Review the employer’s description below for duties, qualifications and application requirements.
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
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Worksite address
caledonia, MI, 49316, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.