BD MDS (Medication Delivery Solutions) R&D is seeking a highly talented and passionate individual to help identify innovative solutions to address current and future health care needs in the medication delivery markets. The available position is for a Staff Engineer with great potential for growth. The successful candidate will join the Verification & Validation team.
In this role, the associate will be accountable for the successful completion of Design Verification and Design Validation (V&V) activities for the assigned Product Development projects. More specifically he/she will be responsible for determining viable design evaluation strategies and putting them into action, collecting outputs and analyzing data, interpreting and reporting out results.
Working within a cross-functional team the associate will be responsible for technical deliverables and execution of activities pertinent to V&V as described in the phase-gated of the product development process including design and development planning, requirements definition, technical specification development, design verification/validation strategy and execution as well as risk/failure modes analysis and root cause determination. He/She will also be responsible for appropriate documentation of these activities.Additionally, the candidate will be expected to participate in concept development of new technologies and products that will help meet current and future clinical unmet needs.
With minimal supervision, the successful candidate will be primarily responsible for supporting design evaluation activities during development and leading Design Verification and Validation to help meet key business objectives. Day-to-day responsibilities may include the following as well as other duties as required:
- Initiate V&V plans and contribute to project plans/timelines
- Provide viable options for evaluation of concepts with quick turn-around
- Participate in risk management activities
- Lead or participate in clinical evaluations such as user studies and design validation
- Develop and establish Design Verification and Validation plans and protocols
- Conduct technical assessment of design inputs. Propose viable verification strategies (e.g. engineering assessment, empirical or analytical methods).
- Create and implement new design verification methodologies, modify existing ones to meet needs. Qualify developed measurement systems/methods appropriate for their intended use.
- Apply core engineering and scientific principles during planning, execution, reporting of V&V activities. Leverage Six Sigma (DMAIC), and Design for Six Sigma (DFSS) principles to reach reliable and robust results
- Solve technical problems using systematic problem-solving and statistical methodologies.
- Investigate root cause of issues and propose solutions
- Collaborate with SMEs within and external to BD to provide best in class solutions
- Stay current with latest trends in medical device verification and validation strategies
- Participate in design review and technical reviews. Lead when appropriate.
- Represent company in external technical committees, conferences, meetings
- Prior experience (minimum 8 years with a BS degree) working in medical device or other regulated industry. Must have a Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or closely a related discipline; Master's degree preferred
- Basic understanding of the requirements management process (e.g. customer requirements vs. product requirements vs. product specification) as well as elements of Design Controls
- Experience with collecting, recording, and interpreting data. Ability to use data with practical assumptions and engineering justifications
- Effective Communication Skills - Ability to convey ideas confidently and succinctly in groups. Persistency and drive to meet objectives within deadlines. Ability to adapt to change.