Staff Product Engineer- Mechanical

Responsibilities

• Keep our wide range of critical medical devices in the market, delivered on time and in compliance with international regulations.
• Continuously improve our products for manufacturability, reliability and cost effectiveness, driving material changes due to supply chain issues and retesting to the latest international standards.
• Assume 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.

Essential Functions & Accountabilities

• 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.

Project Delivering

• 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.

Organizational and Process Effectiveness

• 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.
• 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.

Safety, Efficacy, and Compliance

• 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.

Qualifications

• 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.
• Cross-disciplinary education and/or experience such as mechatronic, electro-mechanical, mechanical-materials, electrical-biomedical, etc is highly desirable.
• Expertise in CAD modeling (Creo and/or SolidWorks), mechanical design and creation of engineering drawings including GD&T – required.
• 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.
• 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.
• 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.

Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.