Senior Product Engineer

Our integrated Front-end Innovation New Product Development and Product Engineering setting provides an exciting opportunity to Product Design Engineers to be involved in a user-centric end-to-end product innovation process spanning from new opportunity incubation via rigorous product development to market launch and subsequent product engineering.

As Senior Product Design Engineer you will be part of the Product Engineering team reporting directly to the head of the Product Engineering group. Scope of this role includes activities pertaining to product upgrades and improvements line extensions as well as new concept incubation activities. Within the scope of this role are electro-mechanical connected systems and devices associated with In-vitro fertilization (IVF) and Assisted Reproductive Technologies (ART). You will also have an opportunity to drive product engineering activities associated with surgical devices instruments and disposables in broader womens health field including Obstetrics and Gynecology (OBGYN).

1. TECHNICAL CONTRIBUTIONS AND INNOVATION

a. Drive troubleshooting coordinate root-cause analysis for complaints and CAPAs and devise solutions and approaches for solving technical problems (solution gameplan) and overcoming development challenges in an inclusive and collaborative fashion.

b. Design and develop and improve 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.

c. Define 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.

d. Ideate conceptualize and build concepts and prototypes to aid incubation of new opportunities or down-select wining solutions for new product developments upgrades or improvements.

e. Create simulation and mathematical models as appropriate to demonstrate functional feasibility of technical solution based on experimental numerical statistical and/or finite-elements tools and techniques.

f. Develop test methods and fixtures for products components and systems simulation evaluation and verification testing.

2. PROJECT DELIVERING

a. Deliver agreed project outcomes on-time and on-budget per project plan.

b. Scope plan and manage execution of assigned project tasks workstreams and deliverables ensuring full alignment with the overall project plan and business objectives.

c. Train mentor and provide technical directions to junior engineers and team members as appropriate to ensure that desirable business outcomes are achieved.

d. Manage execution and relationships with external partners engineering consulting firms and vendors.

3. ORGANIZATIONAL AND PROCESS EFFECTIVENESS

a. Aid and drive an effective cross-functional collaboration ensuring timely and efficient delivery of target business outcomes.

b. Contribute to the assessment of new opportunities acquisition targets competitive products and Intellectual Properties (IPs) to aid competitiveness and differentiation of our business offerings.

c. Support or drive scoping project planning and product requirement definition for new product development upgrades or line extensions as appropriate.

d. Select evaluate and implement new tools techniques and best practices to ensure state-of-the-art product development capabilities and best practices.

e. 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.

4. SAFETY EFFICACY AND COMPLIANCE

a. 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.

b. 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.

Travel:

This role is site based requiring occasional travel relating to cross-functional meetings vendor visits trainings and/or conference attendance.

Expertise in CAD modeling (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 required.

Proficiency with engineering first principles and analytical methods including structural and fluid mechanics required.

Advance 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 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.

Work Environment:

Prolonged sitting in front of a computer

Periodic hands-on work in engineering lab (testing prototyping etc)

Experience:

Significant experience in a medical device product development environment required

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.

Education:

Minimum BS w/ 5 or preferably MS w/ 3 years of combined education and experience in development of medical devices or related fields.