Staff Product Engineer- Mechanical

CooperSurgical; Trumbull (CT); Presencial; USD 85.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Descripción de la vacante

CooperSurgical is seeking a Product Engineer to innovate and improve medical devices. The role requires expertise in CAD modeling and design for manufacturing while ensuring compliance with safety standards.

The ideal candidate has at least 8 years of experience in the medical device field and a strong foundation in mechanical and biomedical engineering. Excellent benefits and a collaborative workplace culture are offered.

Formación

• 8+ years of experience in medical device development.
• Experience with design control guidelines including FDA 820.30.
• Ability to lead technical teams independently.

Responsabilidades

• Design and develop medical device components and assemblies.
• Deliver project outcomes on-time and on-budget.
• Ensure compliance with safety and regulatory guidelines.

Conocimientos

CAD modeling (Creo/SolidWorks)

Mechanical design

Analytical methods (structural/fluid mechanics)

Educación

BS in Mechanical/Biomedical Engineering

Herramientas

Design for Manufacturing (DFM)

Descripción del empleo

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. We are at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

Responsibilities

Product Engineering at CooperSurgical means keeping our wide range of critical medical devices on 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 systems and sophisticated robotic solutions involving IT connectivity, machine learning and AI.

Essential Functions & Accountabilities

• Technical Contributions and Innovation
  • 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, and drive successful verification and validation testing.
  • Ideate, conceptualize, and build concepts and prototypes to aid incubation of new opportunities or down‑select winning solutions for new product developments, upgrades, or improvements.
  • Create simulation and mathematical models as appropriate to demonstrate functional feasibility of technical solutions 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 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
  • 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.
• 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.
  • 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.
• 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 projects and products as applicable per company quality standards, policies, and procedures and well as engineering best practices and functional excellence requirements.

Qualifications

• Minimum BS with 8+ or preferably MS with 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.
• 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.
• 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. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

Equal Employment Opportunity

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.