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Senior Product Development Engineer/ Scientist
KymanoxKing of Prussia, United Statesfull_timeVerifiedPosted 13 Feb 2025
About the role
Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. The Kymanox Product Development & Commercialization team is seeking an experienced Senior Product Development Engineer or Scientist with a strong technical and/or operations background in the pharmaceutical, biotechnology, diagnostics, or medical device industries. Ideal candidates will build on their proven past performance supporting complex product development or life cycle management programs involving drug-device combination products, Class 1/2/3 medical devices, and/or in vitro diagnostics.This position is hybrid with an average of 3 days of week in office located in King of Prussia, PA. Job Description: Utilizes technical expertise and project management skills to advance client development projects in the medical device and combination product space. Basic responsibilities include:
- Preparing technical documentation and analyses independently.
- Acting as technical lead on small programs or leading workstreams on larger programs.
- Presenting work product in client facing meetings.
- Mentoring junior technical staff and reviewing their work prior to client delivery.
- Evaluating client technical documentation and development strategy to provide clear, actionable recommendations for mitigation(s) of challenges.
- Developing detailed project plans, schedules, and overall project strategy.
- Overseeing phase-appropriate client testing activities, including combination product and medical device design verification and human factors testing.
- Technology evaluation, due diligence, and selection.
- CMO due diligence, evaluation, and client representation
- Process improvement, troubleshooting or technology transfer.
- Creating technical documentation supporting product development efforts, including design history files and technical files.
- Post-market design change assessments, technical evaluation and implementation, and commercialization.
- Process validation and post-market process change assessments.
- Regulatory submission authorship.
- Statistical analysis of development and production data
- Versatile and adaptable technical skills
- Able to execute high-profile activities with minimal supervision, manages time wisely and delegates as necessary
- Ability to think strategically
- Adaptable, versatile, and welcomes new challenges
- Extremely detail-orientated and highly organized
- Strong professional presence and presentation skills
- Excellent written and oral English communication skills
- Comfortable providing feedback and influencing internal and external stakeholders
- Emotionally stable and can navigate challenging clients and situations
- Seasoned soft skills – high EQ and team player
- Ability to work effectively with remote team members and/or direct reports
- Tackle problems proactively
- A mindset of innovation and creativity
- Computer and IT savvy
- Thrive in a fast-paced, growing, and dynamic work environment
- Expertly solicit and utilize subject matter expert input
- Value and understand quality
- Uncompromised honesty and integrity
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