Kymanox · 1 day ago
Senior Product Development Engineer/ Scientist
United States
Full-time
Remote
Senior Level
5+ years exp
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Responsibilities
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
Qualification
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Required
Minimum bachelor's degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution.
5-10 years of experience (including advanced degrees) in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.
Significant contributions to complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable.
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.
Preferred
Early career master's and Ph.D. level candidates encouraged to apply.
Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.
Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable.
Benefits
Medical healthcare including dental and vision
Short- and long-term disability
Life insurance
Matching 401(k) retirement plan
Continuing education assistance
Other benefits
Company
Kymanox
Kymanox is a technical products & project management company provides engineering, scientific, regulatory, and process operations support.
201-500 employees
H1B Sponsorship
Kymanox has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2021-08-23Debt Financing· undefined
2021-08-02Series Unknown· undefined
Leadership Team
Stephen M. Perry
CEO
Nicholas Ciccarelli
Chief Technology Officer
Recent News
Globe Newswire
2024-06-03
2024-03-12
Globe Newswire
2024-02-27
Company data provided by crunchbase
