Title: Senior Staff Engineer
Location: US-New Jersey-Franklin Lakes
Job Number: PRO1041T
BD Facts:
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.
BD focuses strategically on achieving growth in three worldwide business segments: BD Medical, BD Diagnostics and BD Biosciences:
BD Medicalis among the world’s leading suppliers of medical devices and the leading innovator in injection- and infusion-based drug delivery since 1906, when BD built the first-ever facility in the U.S. to manufacture needles and syringes.
BD Diagnosticsis a leading provider of products for the safe collection and transport of diagnostic specimens, as well as instruments and reagent systems to accurately detect a broad range of infectious diseases, healthcare-associated infections and cancers.
BD Biosciencesis a world leader in bringing innovative diagnostic and research tools to life scientists, clinical researchers, laboratory professionals and clinicians who are involved in basic research, drug discovery and development, biopharmaceutical production and disease management.
BD revenues for the fiscal year ending September 30, 2012 of $7.708 billion and invested $472 million in research & development.
Job Description:
The Senior Staff Engineer position is responsible for leading the mechanical engineering R&D function to develop and commercialize complex instrumentation patient safety device with multiple subsystems. Specifically, this position will be responsible for the design of a mechanical system with robust and efficient hardware, ensuring a detailed and well-tested design.
The mechanical engineer responsibilities includes defining, clarifying, designing, and documenting design; performing the necessary parametric analysis and testing; recognizing when interface impacts might occur and taking early action to avoid problems.
This position is expected to utilize quantitative approaches to design activities, to technology integration, strong capabilities and experience in mechanical engineering and processes, and diversified interdisciplinary experience and knowledge. This position will work closely with clinical, marketing, medical and operations to enable reliable performance.
Key to developing a highly integrated, safe, and accurate system are managing requirements and risks, establishing and ensuring appropriate processes, following best practices, and creating documentation to support development activities. This position will be part of a cross-functional team that collaborates with external partners, develops and manages requirements, generates system and component concepts, implements the solutions in hardware, performs experiments, analyzes data, and ensures robust verification and validation testing.
Qualifications:
Education:
* B.S in Mechanical Engineering, Systems Engineering, Biomedical Engineering (ME concentration), or Applied Physics.
* Masters or PhD is strongly preferred.
Licenses or Certifications:
* A minimum of 12 years relevant experience or a combination of equivalent education and experience.
* Working knowledge of international standards applicable to medical devices, including ISO13485, ISO14971, and IEC60601 and its collateral standards.
* Design for Six Sigma (DFSS)/Six Sigma experience is preferred.
Experience:
* Comprehensive understanding of medical device product development is required
* Proficiency with one of the CAD design tools (SolidWorks, Pro/E, AutoCAD) is strongly desirable, SolidWorks experience is preferred.
* Electro-mechanical design
* Experience in commercial printing (inkjet, laserjet, etc.) applications preferred
* FEA analysis knowledge including experience with some of the commercial packages such as ABAQUS, ANSYS, COMSOL, Fluent or similar software would be a plus.
* Candidates with strong hands-on skills and experience in model building (robots, aircrafts, boats, etc), machining, mechanics, electronics or other hands-on crafts will have strong advantage.
* Demonstrated competence with conventional mechanical test methods and equipment (e.g., Instron) and/or standard data acquisition, instrument control, and automation platforms such as LabVIEW is required.
* Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies is required.
* Design for Six Sigma
* Self-initiator, results driven and action and detail oriented
Special Skills:
* Coordinate development tasks to include design, verification, validation, integration and formal testing
* Create and maintain programmatic and technical documentation to insure efficient planning and execution
* Ability to identify, break down and solve deep technical problems
* Leadership of mechanical engineering function
* Excellent interpersonal, communication, presentation and influencing skills
* An ideal candidate for this position will have a profound attention to detail, systematic problem solving skills, a strong desire to learn and acquire new skills and knowledge with a strong bias for action.
* With minimal supervision from project leaders, provide advanced engineering skills, technology development, and product evaluation support.
* Plan, implement, monitor and deliver designated tasks and deliverables. Be accountable for success of assigned tasks and deliverables.
* Resolve technical problems. Create solutions for technical problems using systematic problem-solving methodologies.
* Participate in periodic design reviews of projects.
* Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements.
* Design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions.
* Maintain an overview of relevant technologies and products. Ensure compliance with internal quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. Conduct hands-on evaluation of competitive products, materials and procedures.
* Author protocols and reports including engineering studies using basic statistical methods.
* Provide technical guidance and engineering input to plants in diverse geographies. Develop understanding of internal and external customer needs and processes to ensure relevant and innovative solutions.
* Actively participate in training to improve skills. Ensure technical lessons are reviewed, learned, and disseminated. Actively teach and promote learning. Formal and informal written and verbal communication within the team and with the rest of the organization to ensure dissemination of important information.
* Ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures
Knowledge of Specific Procedures/Practices:
* Knowledge of Medical device industry regulations and practices
* Demonstrated hands on experience with Design Control procedures
* Demonstrated knowledge of system and mechanical development, preferably in medical devices/products
* Demonstrated knowledge of electromechanical systems and interfaces
* Ability to work independently
* Disciplined and well organized
* Demonstrated learning agility of new subject matter
* Design for Six Sigma
* Strong coordination, organization, teaming and communication abilities
* Ability to work under pressure and time constraints
* Successfully presents technical information
* Strong coordination, organization, teaming and communication abilities
Job: Product Design / Development