DescriptionThis 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 electromechanical connected systems and devices associated with Invitro 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 womens health field including Obstetrics and Gynecology (OBGYN).
CooperSurgicals purposeful setting of integrated Frontend Innovations and New Product Development provides an exciting opportunity for R&D engineers to be involved in endtoend product development from a user centric frontend innovation process via rigorous product development to market launch.
ResponsibilitiesOrganizational Impact:
This is a highprofile 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 multidiscipline 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 / electromechanical architecture and Lead development of optics systems and analyze / simulate design to understand key parameters and sensitivities. Establish design feasibility by testing mechanical subsystems 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 electromechanical systems. Drive coach and/or oversee definition of design inputs (i.e. product requirements) and technical strategies for an adequate verification and validation approach.
- Aid and drive an effective crossfunctional 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.
- Create formal Verification test protocols run tests and write Verification test reports.
QualificationsKnowledge Skills and Abilities:
- Track record and extensive experience in launching complex optomechanical devices to production in medical device field. Ability todesign 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 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 crossfunctional technical programs.
- Deep knowledge of optomechanical and electromechanical 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 MoldFlow.. 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.
- Handson craft skills and experience with building prototypes 3 D printing and other fabricating concepts fixtures and prototypes.
- Working experience with thermofluidic systems and gas flow management systems
- 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 multilens 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
- Experience with designing injection molded and sheet metal parts
Work Environment:
This role is primarily site based requiring occasional travel relating to crossfunctional 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 electr0mechanical 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.
Required Experience:
Staff IC