DescriptionAbout CooperSurgical
CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. CooperSurgical is 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 womens healthcare providers including testing and treatment options.
CooperSurgical is a whollyowned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical headquartered in Trumbull CT produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found atwww.coopersurgical.
ResponsibilitiesProduct 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 thermosfluidic system 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. Drive successful verification and validation testing.
- Ideate conceptualize and build concepts and prototypes to aid incubation of new opportunities or downselect 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 finiteelements tools and techniques.
- Drive troubleshooting coordinate rootcause 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
- Deliver agreed project outcomes ontime and onbudget per project plan.
- Scope plan and manage 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 and relationships with external partners engineering consulting firms and vendors.
- ORGANIZATIONAL AND PROCESS EFFECTIVENESS
- Aid and drive an effective crossfunctional collaboration ensuring timely and efficient delivery of target business outcomes.
- Contribute to the assessment of new opportunities acquisition targets competitive products and Intellectual Properties (IPs) 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 stateoftheart product development capabilities and best practices.
- Effectively and timely communicate (written and verbal) progress status updates and way forward gameplans associated with project issues challenges and accomplishments to team members crossfunctional 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.
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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.
- Crossdisciplinary education and/or experience such as mechatronic electromechanical mechanicalmaterials electricalbiomedical 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.
- Handson 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 harmbased risk analysis and defining acceptance criteria preferred.
- Experience with electromechanical robotic or digital systems preferred.
- Experience with thermofluidic 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 frontend of innovation process preferred.
As an employee of CooperSurgical youll 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 atwww.coopersurgicalto learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical viaemail the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.
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.
Required Experience:
Staff IC