Engineer, Device Development and Commercialization

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 that 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.                       Job Description:              Kymanox is hiring for an Engineer, Device Development and Commercialization for our Device Development and Combination Products projects. This is a mid-level role, seeking candidates with strong device development background in combination products and experience leading projects and complex project teams. This role will be based in Boston, MA.                     The position will be engaged in leading key aspects of Kymanox’s engineering service offerings and supporting clients with a deep knowledge in combination products. Experience to include prefilled syringes, auto injectors, nasal devices, inhalers, and/or similar products. The role may serve as key interface for clients as subject matter expert (SME) and technical lead for various programs.                     Projects may include any of the following focus areas:       

• Combination Product Development and Commercialization (all aspects)
• Design Controls (e.g., expert DHF support)
• Risk Management
• Design Inputs
• Design Verification and Validation (V&V)
• Human Factors Engineering
• Process Improvement and Troubleshooting
• Technology Transfer and Scale-Up
• Validation (e.g., Shipping, Process)
• Data Analysis, Including Statistical Analysis
• Regulatory Submission Authorship and Review
• Project Management Leadership and/or Support
• Technical Report Authorship, Review, and Formatting
• Manufacturing and Complaint Investigations
• Quality Management Systems (QMS) Support
• Process and Product Development (including design)

 Additional responsibilities can include:       

• Serve as a Single Point-of-Contact (SPOC) on multiple projects as the technical lead representative.
• Review and approval of technically complex documentation to ensure technical competence to relevant local and federal regulations.
• Completion of gap assessments against industry regulations or standards
• Participation in regulatory body inspections or remediation efforts
• Authoring of response letters to regulatory bodies
• Development of policies or standard operating procedures
• Supply chain and vendor management strategy and compliance
• Training (internal and external)
• Technical Project management and meeting facilitation

Desired Aptitude and Skill Set:       

• Strong knowledge of ISO13485, ISO14971, CFR 820.30, and EU MDR
• Resourceful
• Extremely detail oriented
• Ability to work effectively with remote team members and/or direct reports
• Highly organized
• Self-directing, self-pacing
• Excellent written and oral English communication skills
• Understanding of own limitations
• Ability to solicit and utilize subject matter expert input
• Fast learner
• Pleasant and positive communication style
• Strong customer-service aptitude
• Ability to motivate self, team members, and direct reports
• High energy level
• Excellent problem-solving skills
• Seasoned soft skills (i.e., high EQ)
• Team player
• Thrive in a fast-paced, growing, and dynamic work environment
• Technology savvy

Required Educational Background:       

• Bachelor’s degree in Biomedical, Mechanical, or Chemical engineering, or other technical discipline from an accredited institution or equivalent.
• Continuing education or certificates in project management, six-sigma, statistics, engineering, quality, or regulatory affairs is desirable but not required.
• Consideration also given to advanced degrees (e.g., MEng, MS, PhD) where there is demonstrated utilization of advanced schooling.

Experience:       

• 5+ years of experience in development and manufacturing in the pharmaceutical, biotechnology, and combination product sectors is required.
• A demonstrated level of medical device and biologic and/or drug experience is required; overall talent and ability to learn from Kymanox experts is ultimately more important than current experience for long-term success at the firm. .
• Experience with pre-filled syringes, auto pen injectors, co-packaged kits, and/or other combination product platforms is required
• Familiarity with risk management tools and applications
• Familiarity with data analysis tools and applications

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