Prin R-D Engineer

Responsibilities

• Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
• Designs studies to investigate specific life science questions within field of expertise.
• May be involved in product research and development and/or clinical trials.
• Translates research discoveries into usable and marketable products.

Qualifications

• Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering or similar discipline.
• 5 years of experience in medical device process development and manufacturing, with experience of products with electrical functionality preferred.
• Examples of critical thinking and use of statistics.
• Working in a cross-functional teams and leveraging basic PM skills such as project planning, communication, risk management, etc.
• Read and understand quality management system documents and comply with procedures.
• Use scientific problem-solving methodologies such as DMAIC, process map, 5 Whys, 6M, timeline, Is/Is not, etc., and use statistical techniques to quantify confidence and make data-driven decisions.
• Show attention to detail, accuracy, and adherence to quality management system requirements, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance.
• Drive critical path and monitor secondary critical paths for progress, communicating challenges early.
• Work independently, familiar with common analytical techniques and instrumentation, particularly HPLC, MS, LCMS, FTIR, etc., and interpret data and make decisions based on analysis.
• Experience in validation and performance analysis (MSA, IQ/OQ/PQ, TMV) ensuring regulatory compliance and reliability.

Skills

• Process development (process characterization and validation – DOE, PCR, TMV, IQ, OQ, PQ).
• Statistics.
• Strong problem-solving skills.

Benefits

• Ability to work collaboratively and with respect and humility within a cross-functional team to establish manufacturing lines for medical devices, prioritizing safety, quality, service, cost.
• Engage with team to understand goals and current reality, provide solutions, align on path forward, drive/track/communicate progress, adapt as needed with team.
• Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges.
• Project leadership experience, including project planning, communication, risk management, and adherence to quality management system requirements.

Pay

(Not specified)

Schedule

(Not specified)

Benefits

(Not specified)

Pay

(Not specified)

Schedule

(Not specified)

Benefits

(Not specified)