Senior Product Development Engineer
LifeNet Health
- Virginia Beach, VA
- Permanent
- Full-time
- Leadership: Provides oversight to assigned team by supervising, guiding and directing employees to be effective team members. Ensures that everyone is equipped with the right skills, tools, and talents necessary for executing their duties. Using established people processes (performance, development, succession, and career) to ensure that their team's level of performance and capabilities meet current and future standards.
- Product Resource: Serves as the lead engineering resource and/or the project/team lead on multiple concurrent line extensions and/or new products utilizing existing core technologies requiring cross-functional teams. May lead project(s) implementing new technology (high complexity) with a large cross-functional team. Prepares and presents updates to colleagues and management.
- Expertise: Serves as the primary Product Development subject matter expert on a key technology (product / process / equipment)
- Design Control: Coordinates the planning, development, testing, documentation of verification and validation activities including implementation of new and/or improved allograft solutions. This includes drafting and/or guiding the drafting and execution of test plans, protocols and reports utilizing LNH's design control process in accordance with LNH Standard Operating Procedures (SOPs).
- Support: Supports the engineering needs of other LNH departments as determined appropriate.
- A Bachelor's degree in Engineering and eight (8) years of engineering experience in a medical device or similar regulated industry (e.g. aerospace, pharma) OR a Master's degree in Engineering and six (6) years of engineering experience in a medical device or similar regulated industry (e.g. aerospace, pharma).
- Two (2) years of experience in medical device product development.
- Two (2) years of project lead experience or team lead experience (guiding, coaching, mentoring junior engineers).
- Master's degree or PhD in Engineering.
- White or Green Belt Lean Certification: Certification from LifeNet Health Lean University or similar.
- Eight (8) years of experience in the medical device industry or directly related graduate studies.
- Three (3) years of experience in medical device product development.
- Two (2) years of supervisory/ management experience with direct reports.
- Computer Skills: Solidworks, MiniTAB, JMP.
- Project Management Software: Microsoft Project/ Workfront.
- Biomedical Engineering & Technology: Knowledge of the practical application of engineering science and technology to production and development of clinical solutions; cross-functional knowledge in manufacturing, research and/or quality.
- Regulatory Knowledge: Working knowledge of external standards and the application of those to new products / processes.
- People Development: Actively engages in talent management practices (selection, promotion, development and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs.
- Computer Skills: Microsoft Outlook, Word, Excel and PowerPoint.
- Project Management: Ability to manage project activities and meet deadlines as required including use of appropriate quality and design control tools and methods; able to present project information and data to project team, management and above.
- Critical Thinking: Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems; able to lead Failure Mode and Effects analysis (FMEA), root cause analysis, and/or complaint investigations.
- Complex Problem Solving: Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
- Data Analysis: Uses mathematics and engineering principles to solve problems; uses statistics and design of experiment tools to draw conclusions.
- Relationship Management: Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
- Engineering & Technology: Knowledge of practical application of engineering principles to develop process and product solutions; experienced with a number of processes, systems or products; advanced knowledge of design control process and qualification protocols.
- Communication & Presentation: Ability to communicate conclusions and recommended path; able to present complex information to peers and non-technical leadership; able to describe and convince decision makers and senior leadership on recommended path.
- Time Management: Ability to use time in an effective and productive manner with ability to work under pressure with tight timelines, make critical decision and maintain a sense of focus and urgency.
- Regulatory Knowledge: Working knowledge of design control processes and validation best practices.
- Analytical Thinking: Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends.
- 403(b) and Profit Sharing Plan
- Affordable medical, dental, and vision coverage
- Corporate sponsored events for employees
- Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
- Tuition reimbursement
- Personal career, skill, and leadership development opportunities
- Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
- Employee Assistance Program (EAP) for employees and members of their household
- Dedicated and passionate co-workers