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 optomechanical 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 optomechanical 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, optical development partners, and user community to come up with robust designs and solutions.

Essential Functions & Accountabilities:

• Formulate and deliver optomechanical / electro-mechanical architecture and Lead development of optics 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 involving optics systems. Accountable to timely project plan deliverables in cross functional teams utilizing CooperSurgical New Product Introduction (NPI) process.
• Coach team members and collaborators in optics, 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 optomechanical 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 / optomechanical 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 optomechanical and electro-mechanical areas typically obtained through advanced technical education combined with experience. Ability to perform first principles mechanical and optomechanical 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.
• Demonstrated track record of complex high precision optics design including microscopy for cell culture imaging, autofocus, and contrast techniques.
• Lead evaluation and characterization of optical components and system integrations
• Working knowledge of Familiar with assembly techniques of multi-lens optical system, optical alignment and calibration.
• Experience with ray tracing and other optical modeling software (Zemax preferred)
• 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) targeted for precision optical systems
• Understanding of statistical methods including Design of Experiments (DOE)
• Proven experience in designing complex mechanisms
• Knowledge of optical systems, objectives, and Hoffman modulation techniques is preferred
• Working experience with thermo-fluidic systems and gas flow management systems
• Experience with designing injection molded and sheet metal parts

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 Optomechanical Engineering, Mechanical Engineering, Robotics, Mechatronics, or combination of related fields. Advanced degree strongly preferred.