JOB TITLE: Product Development Engineer
DEPARTMENT: Design & Engineering
REPORTS TO: Program Manager
FLSA STATUS: Exempt
WHO WE ARE:
Noble is the global leader in helping patients who self-administer medication. Specifically, Noble’s programs include the manufacturing of medical device training solutions, patient onboarding programs and multisensory product development for the world’s top pharmaceutical brands help patients to self-administer a therapy, correctly and with confidence.
Focused on driving innovation, the company works closely with brand, device, and commercialization teams to develop turnkey solutions that improve onboarding and adherence, bringing value to clients and patients alike.
While, what Noble does as a company is a serious endeavor, our culture on the other hand is full of camaraderie and fun. Monthly company lunches, team outings, ping pong and most importantly the people create an environment of light-heartedness, laughter, and collaboration. We believe in a healthy work/life balance, each other, and innovation; knowing the work we do is helping pharma, healthcare providers, and patients.
Noble is part of Aptar Pharma - Global solution provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide.
The Product Development Engineer is responsible for the design and development of non-invasive medical device mechanical and electro-mechanical systems. The Product Development Engineer will contribute ideas and concepts for new products, product enhancements and product customization through teamwork, engineering project leadership, and excellent project coordination and prioritization skills.
ESSENTIAL JOB FUNCTIONS:
Experience developing products from concept through production
Lead the development of mechanical, electro-mechanical, connected medical devices and accessories
Experience leading projects or project teams with responsibility for project timelines, budget and deliverables
Use established procedures to improve existing medical devices and accessories
Collaborate on user research and human factors strategy and apply to research and design
Aim to design mechanisms that are reliable, and compact (space is often constrained)
Experienced in establishing user needs, system design inputs, hardware requirements, and software requirements for electronically medical devices
Collaborate with manufacturing engineers to ensure manufacturability
Experience and skill in applying and transferring new product knowledge to manufacturing, manufacturing processes, medical device regulations, FDA submissions, testing and planning is required
Extensive experience in mechanical design, including plastic-injection molded parts and metal components
Identify, evaluate and manage suppliers to support product development and prototyping
Optimize the tactile feel for users of devices. This requires precise attention to friction, forces, mechanical feedback, etc.
Conduct FMEA studies and preliminary hazard analyses on critical parts and systems
Develop proof-of-concept, usability testing, and showcase prototypes
Develop and execute product testing protocols to verify and validate product requirements, quality and efficacy, and document results
Ensure design control compliance according to 21 CFR 820 Quality System Regulation and ISO 13485.
Experience within the pharmaceutical and/or medical device industry in the development of medical devices or combination products is preferred
Skilled at technical writing in order to create DHF documentation, product development reports, detailed specifications, drawings, test plans, and Standard Operating Procedures (SOP’s)
Must be confident and capable in a customer-facing role, demonstrate proactive and strategic thinking and be able to handle change and ambiguity
Act as lead engineer in design reviews internally and with customers
REQUIRED MINIMUM QUALIFICATIONS (Education, Experience, Skills):
Bachelor’s degree in Mechanical Engineering or related field from an accredited college
3+ years of mechanical engineering experience
Proficient with 3D CAD software; Solid Works or equivalent
Familiar with additive and subtractive prototyping technologies
Experience with human factors and physical ergonomics
Ability to work on multiple projects simultaneously
Excellent prioritization and project management skills
Experience with intellectual property
Good interpersonal and communication skills
View constraints as the arena in which to apply creativity and ingenuity
Aware of industry trends, new technologies, and quickly acquire new knowledge
Motivated self-starter and have the ability to take initiative and act independently
Accountable to deliver project results on schedule and within budget
Approximate 10% of time traveling
Medical device experience
Understanding of embedded system design at system, integrated, and unit level
Experience with drug delivery devices
Experience with Microsoft Project & Office suite
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
Mental - Requires a relatively high degree of concentration intermittently to compile reports and analyze data approximately 50% of time; periods of mental effort and concentration followed by other aspects of the job with lesser concentration and attention requirements
Physical - Requires walking/standing approximately 20%, sitting approximately 80% and lifting up to 15 lbs. approximately 1% of time; involves repetitive stooping, forward bending and crouching approximately 10% of time
Manual Dexterity - Requires use of hands, arms and feet for repetitive lifting; use of hands and arms to operate computers, copy machine and other general office equipment and to record written information
Audible Demands - Requires ability to hear verbal instructions and to communicate with internal departments and outside sources in person and via telephone
Visual Demands - Requires ability to read written instructions, correspondence and other documentation as well as operate office equipment such as computers and printers. Color and depth perception not necessary
Environmental - Requires capability of performing essential job functions in an established office environment under lighting and climate control tolerances. Noise level is moderate