Senior Product Engineer- Mechanical

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 women's health field including Obstetrics and Gynecology (OBGYN).

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.

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 (IP's) 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.

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 (IP's) 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.