Staff Product Engineer- Mechanical

CooperCompanies•Trumbull, CT

13h

About The Position

Product Engineering at CooperSurgical means keeping our wide range of critical medical devices in the market, delivered on time and in compliance with international regulations. This means continuously improving our products for manufacturability, reliability and cost effectiveness, driving material changes due to supply chain issues and retesting to the latest international standards. This is a technical leadership opportunity assuming full ownership of product engineering workstreams, subsystems and/or specific products and deliverables in the domains ranging from simple disposable devices to complex thermos-fluidic system and sophisticated robotic solutions involving IT connectivity, machine learning and AI.

Requirements

Minimum BS w/ 8+ or preferably MS w/ 5+ years of combined education and experience in development of medical devices or related fields.
Mechanical or biomedical engineering experience or combination with other related fields in medical device or related industries is required.
Expertise in CAD modeling (Creo and/or SolidWorks), mechanical design and creation of engineering drawings including GD&T – required.
Proficiency with engineering first principles and analytical methods including structural and fluid mechanics – required.
Advanced understanding of Design for Manufacturing (DFM) – required.
Understanding of statistical methods including design of experiments – required.
Ability to plan activities and lead technical teams or work independently with minimal direction – required.
Hands-on craft skills and experience with building, fixing, servicing and/or fabricating concepts, fixtures, prototypes or similar – required.

Nice To Haves

Cross-disciplinary education and/or experience such as mechatronic, electro-mechanical, mechanical-materials, electrical-biomedical, etc is highly desirable.
Medical device development experience with thorough understanding of design control guidelines including verification and validation methods according to FDA 820.30 and ISO 13485 – preferred.
Experience with translating customer to product requirements, conducting harm-based risk analysis and defining acceptance criteria – preferred.
Experience with electro-mechanical, robotic, or digital systems – preferred.
Experience with thermo-fluidic systems and transport phenomena – preferred.
Experience with FEA and/or CFD mathematical modeling – preferred.
Proficiency with Design for Six Sigma (DFSS) – preferred.
Experience with identifying latent user needs and front-end of innovation process – preferred.

Responsibilities

Design and develop components and assemblies using first principles, applied mechanics, fluid and thermodynamics, mechatronics, and mechanisms as well as engineering best practices associated with CAD, GD&T, Modeling, and DFSS.
Define testable design inputs (i.e., product requirements), develop design outputs (i.e., product specifications), define technical strategies for an adequate verification and validation approach.
Drive successful verification and validation testing.
Ideate, conceptualize, and build concepts and prototypes to aid incubation of new opportunities or down-select wining solutions for new product developments, upgrades, or improvements.
Create simulation and mathematical models as appropriate to demonstrate functional feasibility of technical solution based on experimental, numerical, statistical, and/or finite-elements tools and techniques.
Drive troubleshooting, coordinate root-cause analysis and devise solutions and approaches for solving technical problems (solution gameplan) and overcoming development challenges in an inclusive and collaborative fashion.
Develop test methods and fixtures for products, components, and systems simulation, evaluation, and verification testing.
Deliver agreed project outcomes on-time and on-budget per project plan.
Scope, plan, and manage execution of assigned project tasks, workstreams, and deliverables ensuring full alignment with the overall project plan and business objectives.
Train, mentor, and provide technical directions to junior engineers and team members as appropriate to ensure that desirable business outcomes are achieved.
Manage execution and relationships with external partners, engineering consulting firms and vendors.
Aid and drive an effective cross-functional collaboration ensuring timely and efficient delivery of target business outcomes.
Contribute to the assessment of new opportunities, acquisition targets, competitive products, and Intellectual Properties (IP’s) to aid competitiveness and differentiation of our business offerings.
Support or drive scoping, project planning and product requirement definition for new product development, upgrades, or line extensions as appropriate.
Select, evaluate, and implement new tools, techniques, and best practices to ensure state-of-the-art product development capabilities and best practices.
Effectively and timely communicate (written and verbal) progress status updates and way forward game-plans associated with project issues, challenges and accomplishments to team members, cross-functional partners, stakeholders, and managers.
Drive medical devices design control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective products.
Maintain technical documentation for project and products as applicable per company quality standards, policies, and procedures and well as engineering best practices and functional excellence requirements.