Principal Engineer, Device Design and Development Technical Lead

Biogen-posted 8 months ago
$156,000 - $215,000/Yr
Full-time • Senior
Hybrid • Cambridge, MA
Chemical Manufacturing
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Biogen is seeking a qualified candidate for the role of Principal Engineer, Technical Lead in the Device Development group. The position will lead the design and development of patient-centric, safe, reliable, and innovative devices. Beginning with continuous research of cutting-edge technology to develop multidisciplinary drug delivery systems to support Biogen's drug product pipeline. Effectively and efficiently bring optimized products to market through rigorous science and engineering by leveraging external partnerships in collaboration with internal Human Factors, Packaging, Manufacturing, Engineering, Quality, Regulatory Affairs, and other cross-functional stakeholders. This is a hybrid role to be based at our Headquarters in Cambridge, MA.

  • Design innovative drug delivery devices and combination products aligned to Biogen's drug product pipeline.
  • Identify multiple solutions and recommend a course of action to leadership.
  • Make complex decisions and troubleshoot in ambiguous situations across the department.
  • Create an environment of experimentation and work across disciplines and functions to advance novel drug delivery solutions.
  • Optimize design for usability, design robustness, and manufacturability.
  • Apply technical, functional, and business knowledge to design experiments and solutions that contribute to Biogen's strategic priorities.
  • Create experimental plans, analyze data, and write reports.
  • Develop and promote the use of novel approaches within your area of expertise.
  • Routinely investigate and create innovative solutions, hypotheses, and methodologies to solve unique and complex problems.
  • Assist with project planning, including organizing experiments, staff, and meetings.
  • Engage in publishing internal and external technical documents, and presentation of own scientific work, as required.
  • Collaborate with external clinical experts and industry to expand business opportunities.
  • Develop relationships with other groups.
  • Communicate difficult technical concepts and influence others to appreciate a novel point of view.
  • Present supportive arguments for complex ideas and projects to internal governance bodies and external stakeholders.
  • Contribute to the writing of regulatory filings and answer regulatory questions.
  • Participate in face-to-face meetings with regulatory agencies.
  • Liaise with third parties such as contract design and manufacturing companies, testing labs, and other experts.
  • Lead technical team and/or cross-functional project teams.
  • Bachelor's degree in engineering.
  • 10+ years' experience in medical device design, especially drug delivery systems.
  • Demonstrated experience in combination products (such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, reconstitution devices, etc.).
  • 5+ years' experience facilitating the interface between the pharmaceutical company and the medical device vendor base.
  • Ability to communicate and direct supplier activities at the management level.
  • Advanced degree in Biomedical, Electrical, or Mechanical engineering, with 8+ years of experience in medical device design (Class II and Class III), preferably including the design of drug infusion pumps, catheters, and active and passive implantables.
  • Proven experience developing and launching a drug combination product through the entire product development lifecycle.
  • Deep device design and development knowledge of first principles analysis, tolerance analysis, FEA, DOE, Design for Six Sigma (DFSS), Design for Manufacturing (DFM), etc.
  • Deep knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in the US, EU, and other regions.
  • Experience with ISO 13485, ISO 14971, 510k, PMA, MDD, MDR.
  • Deep understanding of new product introduction, design, and development of extruded, molded, and/or assembled device products, as well as testing and modeling methodologies.
  • Demonstrated good decision-making capability and driving alignment within matrix organization.
  • Medical, Dental, Vision, & Life insurance
  • Fitness & Wellness programs, including a fitness reimbursement
  • On-site childcare facility in Cambridge, MA
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company-matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation
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