Title: Engineer I
Location: US-New Jersey-Franklin Lakes
Job Number: PRO104JS
Within BD Medical Surgical Systems (MSS) Research & Development, the associate in this position will have a unique opportunity to support Product Verification efforts as part of the Advanced Product Development Services team. This is a group that supports all product platforms across MSS and this associate will significantly contribute to BD's future growth. The APDS team is seeking a highly talented and passionate individual to help the team identify innovative solutions to address current and future health care needs in the medication delivery markets. The associate will contribute to the product verification activities required for sustaining existing and commercialization of various types of new medical device products used in drug delivery.
This position will support the Product Engineering team and lead and/or contribute to product verification activities focused on identifying, developing, and implementing solutions to support the current product portfolio. As an Engineer I, the ideal candidate will perform test method development, product testing, measurement system development & analysis, test fixture design, aid in design verification strategy, writing of protocols & reports, and data analysis. In addition, this person will be capable of identifying and breaking down technical problems resulting in robust solutions. The ideal candidate will participate in executing technical and cross-functional project work which may include all phases of product development, including design and development planning, requirements definition, product development, root cause analysis, test method development, and design verification/validation. Additionally, the candidate may be expected to participate in the development of new technologies for testing products that will help meet current and future clinical unmet needs.
Primary Duties / Responsibilities
* Support design and development activities for products within the current portfolio offerings as well as new product development. These activities include, test method & measurement system development and validation, fixture design, testing optimization, and testing in support of design verification and design validation.
* Participate in executing technical project work. This will involve the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
* Support project plan development and contribute to development of Design Verification strategy.
* Contribute to a culture of innovation by proactively generating novel concepts to improve current product performance or to provide new features that enhance current products’ ability to address customer needs.
Qualifications:
Requirements include:
* Minimum of 1 year experience as a product testing or design / development engineer in the medical device or pharmaceutical industries.
* BS in Mechanical or Biomedical Engineering or closely related disciplines.
* Proficiency in SolidWorks or other equivalent 3-D CAD modeling software and familiarity with drawing standards.
* Basic ability in conceptualizing and designing mechanical test fixtures.
* Experience with utilizing various test methods and instruments such as Instrons, leak test equipment, etc.
* Basic understanding of the product development process.
* Basic understanding of the requirement management (e.g. customer requirements vs. product requirements vs. product specification).
* Some prior experience in a technical role on a team.
* Basic understanding of medical device product development risk management methodologies (i.e. FMEA/EURA).
* Some experience with fixture design including basic machining considerations and Measurement Systems Analysis (MSA)/Gage R&R studies.
* Hands-on experience operating and programming various types of basic materials testing equipment, such as Instron or similar equipment, Labview, and contact-based dimensional metrology (pin gages, CMM).
* Basic understanding of the principles behind sample size determination for variable and attribute testing.
* Basic statistical techniques including descriptive statistics and hypothesis testing (t-test, F-test, etc), analysis of variance (ANOVA).
* Proficiency with statistical software.
* Experience with delivering on-time to an existing project plan.
* Strong analytical and problem-solving skills with demonstrated capability of breaking down complex technical challenges to identify root cause and find innovative and robust solutions.
* Demonstrated ability to make practical assumptions with engineering justifications as appropriate.
* Demonstrated ability to clearly and effectively communicate (verbal & written) concepts, ideas or knowledge to others.
* Drive for results, process effectiveness, continuous versatile learning, customer focus, and team work.
Preferred Skills:
* Relevant 3 years experience with FDA Class II or III medical devices, FDA Design Controls (i.e. 21 CFR 820) and related regulatory standards (e.g. ISO)
* MS in Mechanical or Biomedical Engineering or closely related disciplines
* Proficiency in GD&T per ASME Y14.5
* Proficiency in conceptualizing and designing mechanical test fixtures.
* Experience with optimizing various test methods utilizing a variety of equipment.
* Experience with testing form, fit and function product changes through a structured, phase-gated, product development process.
* Demonstrated understanding of the requirements management process as well as experience in design verification strategy and implementation.
* Demonstrated capability in working with a cross-functional team, including regulatory, quality, manufacturing, marketing and medical.
* Experience with developing a device and /or package design FMEA or EURA.
* Good understanding of MSA/Gage R&R strategy and proficiency in design of fixtures.
* Experience with advanced testing or characterization, e.g. non-contact dimensional metrology (Vision, CT, X-ray), mechanical or material testing using custom instrumented set-ups including variable and attribute testing
* Experience with designing variable testing to replace/minimize attribute testing requirements
* Proficiency with advanced applications of statistics such as design of experiment (DOE), sampling techniques (OC-curve), regression modeling (linear & non-linear)
* Proficiency with Minitab
* Experience with developing, managing and tracking to a project plan with demonstrated on-time delivery.
* Basic understanding of IP considerations, e.g. invention disclosure vs. patent application, types of patent filings, trade secret. vs. patent, etc.
* Experience with systematic problem-solving methodologies (e.g. root-cause analysis, fishbone diagram, fault tree, etc)
* Demonstrated advanced ability to make practical assumptions with engineering justifications as appropriate.
* Ability to tailor communication content and format depending on the audience.
Job: Product Design / Development