Scope:
This is a highly technical role inside the CooperSurgical R&D New Product Development (NPD) group developing mechanical and electronics systems in support of various electromechanical product launches. Within the scope of this role are electro-mechanical connected systems and devices associated with In-vitro Fertilization (IVF) and Assisted Reproductive Technologies (ART). This role will also have an opportunity to be involved in activities associated with surgical devices and instruments in a broader women’s health field including Obstetrics and Gynecology (OBGYN).
CooperSurgical’s purposeful setting of integrated Front-end Innovations and New Product Development provides an exciting opportunity for R&D engineers to be involved in end-to-end product development from a user centric front-end innovation process, via rigorous product development, to market launch.
Organizational Impact:
This is a high-profile specialist role responsible for defining architecture, designing, prototyping, and verifying electro-mechanical designs for complex product development initiatives. The Staff Mechanical Engineer is expected to work independently under limited supervision and will be responsible for entire project workstreams within mechanical engineering domain. This role will provide inputs on R&D technical directions and is expected to collaborate closely with multi-discipline cross- functional teams with significant impact on departmental results. The Engineer in this role is expected to interface with external suppliers, development partners, and user community to come up with robust designs and solutions.
Essential Functions & Accountabilities:
- Formulate and deliver mechanical / electro-mechanical architecture and Lead development of mechanical systems and analyze / simulate design to understand key parameters and sensitivities. Establish design feasibility by testing mechanical sub-systems and demonstrating statistical capability for critical functions.
Drive medical device Design Control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective electro-mechanical systems. Drive, coach and/or oversee definition of design inputs (i.e., product requirements) and technical strategies for an adequate verification and validation approach.
- Create formal Verification test protocols, run tests, and write Verification test reports.
Aid and drive an effective cross-functional collaboration ensuring timely and efficient delivery of target business outcomes. Accountable to timely project plan deliverables in cross functional teams utilizing CooperSurgical New Product Introduction (NPI) process.
Coach team members and collaborators in design control processes and best practices. Lead and mentor interns and junior engineers.
Communicate key technical content to parties within and outside of own function (R&D). May have responsibility for communicating with parties external to the organization and manage external development partners to meet project deliverables on time.
Work to influence parties within and outside of the technical function at an operational level regarding policies, practices, and procedures.
Drive improvement, refinement and consistent global implementation of product development procedures and best practices as well as other applicable Design Control guidelines.
Qualifications
Knowledge, Skills and Abilities:
- Track record and extensive experience in launching complex electro-mechanical devices to production in medical device field. Ability to design and develop components and assemblies using first principles, applied mechanics, fluid and thermodynamics, mechatronics, mechanisms, and best practices.
- Track record and deep understanding of development approaches and strategies for effective execution and delivery with an outcome focused mindset including process discipline and drive for timely project completion.
- Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from project engineers and consultants to key opinion leaders and executives.
- Previous technical leadership or program management experience including planning, coordinating, and managing R&D and/or contract manufacturing projects, external engineering consultancies and/or cross-functional technical programs.
- Deep knowledge of technical mechanical and electro-mechanical areas typically obtained through advanced technical education combined with experience. Ability to perform first principles mechanical calculations and simulations (e.g. FEA, CFD, Mold-Flow,.. simulations) to confirm concept feasibility.
- Medical device development experience with thorough understanding of Design Control guidelines as defined by FDA, MDR, ISO, CSI, and other standards. Ability to translate User Needs to Design Inputs to creating Verification Test protocols, and perform verification testing, and publish Verification Test report.
Hands-on craft skills and experience with building prototypes, 3 D printing, and other fabricating concepts, fixtures, and prototypes.
- Working expertise in CAD modeling (e.g. SolidWorks), mechanical design and creation of engineering drawings including GD&T.
- Advance understanding of Design for Manufacturing (DFM)
- Understanding of statistical methods including Design of Experiments (DOE)
- Working experience and expertise in designing plastic injection molded parts with tight tolerances. Experience with IVF dish design is preferred.
- Ability to predict molded part shape (e.g. warpage,..) using Mold Flow or equivalent tools
- Good understanding of mold construction and trade off between gate types, cooling lines, etc.
- Experience designing sheet metal parts
- Experience with thermo-fluidic systems and gas flow management is preferred
Work Environment:
This role is primarily site based requiring occasional travel relating to cross-functional meetings, vendor visits, trainings and/or conference attendance. Prolonged sitting in front of a computer can be expected as well as working in the lab handling electrical equipment and performing testing.
Experience:
Minimum of 7 years of closely related experience in development of complex electr0-mechanical systems in medical device industry.
Education:
Minimum of Bachelor of Science Degree in Mechanical Engineering,Robotics, Mechatronics, or combination of related fields. Advanced degree strongly preferred.
