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Principle Device Quality Engineer, Combination Product Lead & Risk Management
Location:
Cambridge, MA
Description:
Job Description About This Role Biogen's Product Development Quality function is looking to hire a Principal Device Quality Engineer (QE). This role provides a direct connection between the design and development of medical devices and combination products with the greater organization, ensuring compliant implementation of design in Biogen's validated systems. Further, this role will be established as the SME for risk management and will be responsible for leading Lifecycle management programs, and post marketing commitments for combination products and standalone medical devices. This candidate is responsible for ensuring that the quality of product meets GMP standards, Biogen standards, ISO 13485, and ISO 14971 specifications and is compliant to the regulatory filing. What You'll Do Primary QE oversight for early and late-stage device design/development and manufacturing deliverables. Core member of quality and design and development team representing QE perspectives. Oversee quality and Risk Management aspects of GMP activities for product manufactured and tested at Biogen's CMOs. Manage the QA interface with manufacturing and testing partners to ensure on-time compliant manufacturing and testing. Responsible for implementation of design in Biogen's validated systems such as PLM, Track Wise, and Oracle. Responsible for E2E QE support from design and development to commercialization, and process /analytical method validation as it relates to unit operations for the manufacture of product, including lifecycle management and Post-Marketing Commitments. Ensuring that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control (21 CFR 820.30) and risk management (ISO 14971) requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses. Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions. Execute impact and risk assessments in response to product / quality system failures, investigations, and regulatory inspections. Provide Device Quality expertise to influence and support decisions across the Biogen Supply Chain. Support internal audits, external audits of CMOs and regulatory inspections at CMOs as needed. Who You Are The incumbent must forge strong relationships with both internal and external stakeholders, possess effective interpersonal, as well as strong verbal/written communications skills, and a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. Thie ideal candidate must be comfortable working in a fast-paced environment with and minimal direction and ability to thrive in ambiguity as well as changing priorities. Qualifications Required Skills Minimum, a BS degree. Life Sciences, Engineering or related field preferred, an advanced degree (MS or Ph.D.) is highly preferred. Minimum of 10 years of experience in pharmaceutical/MedTech industries, specifically in the areas of development and commercialization of combination products. Thorough understanding of Design Controls and cGMP requirements compliant with ISO 13485 and the QSR (21 CFR Part 820) as per 21 CFR 820 and ISO 9001, ISO 13485:2003, and ISO 14971:2007 is strongly preferred. Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans required. Good understanding of statistical tools and validation/verification techniques. Strong knowledge of Risk Management related to combination products and medical Devices. Experience in managing external development and manufacturing or other such business partnerships. Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner is required. Comprehensive knowledge of US and EU GMP, GDP and MDR regulations. Additional Information The base compensation range for this role is $121k - 148k - 175k. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions. Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9c4211ea-1e2f-4e35-8042-8db2c6b8de9f
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Principle Device Quality Engineer, Combination Product Lead & Risk Management is a Quality Assurance Quality Engineer Job at Biogen located in Cambridge MA. Find other listings like Principle Device Quality Engineer, Combination Product Lead & Risk Management by searching Oodle for Quality Assurance Quality Engineer Jobs.
Principle Device Quality Engineer, Combination Product Lead & Risk Management is a Quality Assurance Quality Engineer Job at Biogen located in Cambridge MA. Find other listings like Principle Device Quality Engineer, Combination Product Lead & Risk Management by searching Oodle for Quality Assurance Quality Engineer Jobs.