- Doctoral Degree
- Bachelor's Degree
- Master's Degree
- Technical Writing
- Lean Manufacturing
- Clinical Trials
This is a high-level research and development engineering position. Requires a high-energy individual with excellent teamwork, partnering and negotiation skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on engineering position that leverages medical device development / quality / manufacturing experience in new product and process development. Responsible for both the technical aspects of product design and development as well as the translation of marketing requirements into product specifications. Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction.
Essential Job Functions
Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
Maintains a professional working relationship with internal & external customer and support staff.
Participates and leads cross-functional teams.
Provides technical support on components, material methods, systems and equipment.
Develops physical and functional test requirements to assure specifications and regulations are met.
Writes and approves protocols, reports and data.
Manages testing outlined in protocols and test methods.
Manages/develops validation studies on equipment & processes.
Conduct complaints investigations.
Understands and follows company procedures and regulatory requirements.
Participates in and provides input to training on department & division procedures, and policies
Manages project planning, budgeting, scheduling and tracking.
Plans and coordinates engineering test builds.
Analyzes problems in design, process and test development. Recommend/implement solutions.
Prepares and presents oral and written project updates and technical discussions.
Develops and implements procedures/policy.
Experience as the lead R&D engineer on a medical device product development program
Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
Design capability with small plastic and metal parts
Demonstrated proficiency with Geometric Dimensioning and Tolerancing (GD & T)
Significant experience in product verification and validation testing, medical device new product development and rapid prototyping.
Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage).
Clinical trial and/or animal trial experience
Proficient in technical writing of protocols and reports.
Proven capability in writing clear and detailed testing and product assembly procedures.
Impeccable documentation skills and adherence to design control procedures and GLP
Demonstrated experience in application of lean manufacturing principles.
Comfortable in a dynamic working environment with a high amount of change
Demonstrated ability in using statistical experimental design and analysis techniques (i.e. Taguchi Design of Experiments)
Familiarity with Solid Works and/or FEA software
Ability to make and present engineering decisions.
Additional Desirable Qualifications Skills and Knowledge
A bachelor's degree in Mechanical Engineering or other engineering discipline is required.
Education and/or Experience
Bachelors degree in science or engineering plus four to eight years, (Master’s degree plus two to six years, or Ph.D. degree with zero to four years) of engineering experience within the medical device or equivalent industry.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Becton Dickinson is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.