Principal Product Design Engineer, EndoMech/Energy

Job description

Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a R&D Principal Product Design Engineer, EndoMech/Energy, located in Cincinnati, OH. Assignment length for the Principal Design Engineer, expected to last approximately 12 months.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

Our R&D team of engineers, designers and technical experts are in the forefront of technology in the medical device industry. You will be making a vital contribution to the New Product Development pipeline and transforming patient care through innovation. Our Design Engineer executes specific & general assignments/projects that provide innovative, functional, cost effective & validated product designs in a team based environment.

The Principal R&D Product Design Engineer is responsible for leading the development of a complex innovative, functional, cost effective product concept and/or validated product designs at the product family level. Provides guidance and direction to less experienced engineers in a project lead engineering role. Leads the cross-functional partner strategy alignment. Develops and monitors project schedules and budgets. Plays an active role in the establishment and execution of mentoring programs for engineering associates. Executing specific and general assignments that provide innovative, functional, cost effective and validated product designs.

KEY JOB RESPONSIBILITIES:
· Apply knowledge of general engineering principles, materials, DFMA and reliability to achieve product design requirements. Work one-on-one with customer stakeholders to identify procedure and/or product opportunities and evaluate potential technical solutions. Interpret customer and marketing input to define technical design requirements.
· Maintain idea notebooks actively generate and submit novel, innovative product, and process or method ideas into the intellectual property database.
· Utilize JOC (jobs, outcomes and constraints), VOC (voice of customer) methodologies and surgical procedure knowledge to define product and design options.
· Provide innovative platform, product, system, sub-system and component design solutions.
· Perform detailed design analysis and provide input or approval for detailed design specifications.
· Establish appropriate statistical testing strategies to insure adequate safety factors or margins.
· Perform appropriate statistical product testing to insure adequate safety factors or margins.
· concepts, breadboards and prototyping
· Provide support to patent attorneys for patent filing.
· Consult with materials technology group for biomaterial approvals.
· Assist in developing and monitoring project plan, budget, contingency plans and work estimation.
· Contribute to and/or coordinate integration of complex sub-system product medical device designs.
· Provide technical leadership to product development team.
· Provide peer feedback and may mentor junior associates as required.
· Utilizes geometric tolerance methods (GD&T) and sub-system/system stack-up methodologies to translate performance level and system level requirements to drawings and components.
· Supports the application of manufacturability principles (DFM/A, tooling, process, cost) to component and product designs.
· Conduct and develop comprehensive Design FMEA's to analyze the impact of design related risks.
· Utilize product design and development methodologies (DMAIIC, DMADVV, DTV) to ensure products bring value to customer.

TECHNICAL (MECHANICAL)
· Develop free-body diagrams, calculate stress and strain values, and Formulate tolerance stack-ups.
· Other responsibilities may be assigned and not all responsibilities listed may be assigned

SUPERVISORY RESPONSIBILITIES: May supervise co-ops, contractors, technicians as required.

TRAVEL REQUIREMENTS: Domestic and international travel, as required

Desired profile

Qualifications :

EDUCATION / DEGREE /EXPERIENCE REQUIRED
·  A minimum of BS or MS engineering degree, required.
·  Advanced degree preferred.
·  8 years minimum of design-related regulated industry (i.e. aerospace, automotive, etc.) experience, required.
·  Experience in FDA-regulated medical products or device industry working in a team base environment, preferred.
·  Six Sigma Green or Black belt preferred.
KEY SKILL / KNOWLEDGE REQUIREMENTS:
·  Basic understanding and working knowledge of current US & foreign government regulations regarding manufacture & commercial distribution of medical devices.
·  Effective oral, written, and presentation communications; Technical writing: protocols, testing results, procedures, status and special reports;
·  Project management skills;
·  Knowledge and understanding of medical regulations and their impact on business, ISO (International Organization for Standardization) and GMP (Good Manufacturing Practices);
·  Information and risk analysis skills; Quality, statistical process controls;
·  Knowledge of part manufacturing processes and tooling methodologies;
·  Effective team interpersonal skills; Conflict analysis and resolution;
·  Consulting, design review, and constructive feedback;
·  Negotiating (e.g., internal and external customers); Networking; Able to work efficiently and effectively in an ambiguous environment;
·  Able to adapt to shifting priorities; Able to handle rapid pace environment; Able to resolve problems / conflicts;
·  Able to take initiative and be self-managing;
·  General design engineering principles; Design of experiments (DOE); DFMA (design for manufacturing and assembly) principles;
·  Knowledge of intellectual property fundamentals and legal processes for managing intellectual art;
·  Working knowledge of mechanical testing of systems, sub-systems and components;
·  Knowledgeable of medical terminology, procedures and instrumentation.
·  Ability to collaborate and provide design and manufacturing guidance to outside design and manufacturing partners to successfully bring robotic instruments to market.
·  Ability to collaborate and build technical relationships across internal and external boundaries, and to influence without direct authority.
·  Experience translating high-level customer needs into technical options and analyzing the tradeoffs and business impact Understanding of surgery, surgical procedures, and the design and application of surgical devices, as well as the quality system / regulatory environment.
·  Build prototypes, products, and systems for testing; set up and run laboratory simulations.
·  Design test procedures and coordinate testing.
·  Conduct tests, document results, and develop written reports.
·  Strong understanding of verification and validation methodologies and test procedures.
·  Conduct and/or participate in technical design reviews of requirements, specifications, designs, etc.
·  Strong understanding of design control; the ability to develop and execute design plans, design verification and validation.

TECHNICAL (MECHANICAL):
·  Free-body and stress-strain analysis and FEA (finite element analysis); Strength of materials and failure analysis; Geometric tolerance and tolerance stack-up analysis (GD&T); Measurement system analysis including gage repeatability and re-calibration system and methodology; Plastic resins, ferrous and nonferrous metals, adhesives, elastomers and sealants.

COMPUTER SKILLS:

Special design analysis software, (e.g., FEA, mold flow), CAD / CAM software proficiency

Assignment length for the Principal Design Engineer, expected to last approximately 12 months.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.