Sr Design Engineer

Talent Acquisition Team•Caledonia, MI

4d•Onsite

About The Position

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

Requirements

Bachelor of Science Degree in Engineering or closely related 4-year technical degree is required
7+ years of medical device engineering experience 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
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
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

Nice To Haves

PMP certification preferred
Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance Requirements) and/or IEC 62304 (Medical Device Software Lifecycle Requirements) preferred.
Preferred experience using engineering programs such as SolidWorks, Minitab, TOPS, similar.

Responsibilities

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
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.
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.
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