Senior Project Lead - Device / Combination Product Development

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Job Description

About This Role

The position will lead the execution of medical devices, combination products and packaging projects, ranging from various route of administration like SC, IM, IV, Intrathecal and supporting patient-centric, safe, reliable, and innovative devices, digital devices, and packaging technology projects, aligned to the drug pipeline, as well as execute, communicate deliverables, plans with internal stakeholders and external partners for Biogen.

The position will lead cross functional teams to drive key activities throughout development phases of device and combination products, and facilitate the deliverables to support regulatory filing, product launch and post market surveillance.

WhatYou’llDo
  • Will lead Biogen’s cross functional Combination & PMA Device Development efforts specific to prefilled syringes, auto-injectors, pens, on-body injectors, transdermal, delivery to CNS and packaging solutions.
  • The ideal candidate will be an experienced project lead that can effectively and efficiently bring optimized products to market by leveraging external partnerships in collaboration with internal Technical Design, Human Factors, Packaging, Manufacturing Science, Engineering, Quality and Regulatory Affairs etc.
  • The candidate is considered a device subject matter expert (SME) and will provide project and engineering leadership in device/packaging and/or system identification, feasibility, development, qualification, launch readiness and commercialization for delivery systems and packaging.
  • Area of focus will be on leading a development team and where needed providing guidance regarding identification of user needs, product requirements and specification development, feasibility test development, design verification and validation testing, human factors, risk assessments, DHF creation, general project team support, and extensive collaboration with both internal stakeholders and external development partners.
  • Utilizes effective and efficient project management tools and best practices to deliver project goals
  • Identifies applications of functional knowledge and existing methodologies to lead teams to solve complex problems; provides advice and strategic direction on a wide range of issues within area of subject matter expertise.
  • Liaise with third parties such as specialist manufacturers, design consultants and contractors
  • Lead device and packaging selection and liaison with cross functional stakeholders in Early and Late-stage development and LCM projects
  • Work and manage key interfaces and line functions in manufacturing, quality assurance, supply chain, and regulatory to progress device and packaging deliverables.
  • Identify multiple solutions and recommend a course of action to leadership; Make complex decisions and troubleshoot in ambiguous situations
  • Develop relationships with other groups. Communicates difficult concepts and negotiates with others to adopt a different point of view; Presents supportive arguments for complex ideas and projects to internal governance bodies and external stakeholders in a way that persuades them to adopt a different point of view, when appropriate
  • Plays critical role in facilitating write-up of regulatory filing and answering regulatory questions. Participates in face-to-face meeting with regulatory agencies
  • Strong communication, collaboration and team building skills; ability to connect with all levels of the organization.
  • Oversee the project execution in compliance with design control SOP.
  • Oversee all aspects of the development process including pertinent DHF deliverables.

Who YouAre

Who YouAre

You are an ambitious leader with exceptional interpersonal and communication skills, with an ability to communicate across all levels of the organization. You excel in managing complexity and can influence behaviors, negotiate and resolve challenges with tact and diplomacy.

You have experience leading cross-functional project teams with proven results in meeting project deadlines and customer expectations.

Qualifications

Required Qualifications:
  • Bachelor’s Degree in Engineering
  • 10+ years’ experience in design, development and commercialization of medical devices, packaging, project management, tooling, injection molding, extrusion, assembly, and production controls for assembly.
  • Understanding of new product introduction, design, and development of extruded, molded and/or assembled device products as well as testing and modeling methodologies.
  • Knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e., FDA QSR 21 CFR 820 / ISO13485 quality system requirements, ISO 11608, and other relevant global standards).
  • Experience developing multiple device and combination product device products from research through registration and launch.

Preferred Qualifications:
  • Master’s Degree or MBA in mechanical or related engineering discipline with 8+ years’ experience.
  • Proven track record of developing and gaining regulatory approval of drug delivery systems.




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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