SomervilleRecruiter Since 2001
the smart solution for Somerville jobs

Senior/Principal Combination Product Design Quality Engineer (DQE)

Company: Alnylam Pharmaceuticals
Location: Somerville
Posted on: January 12, 2021

Job Description:

Job Description - Senior/Principal Combination Product Design Quality Engineer (DQE) (200142)Job Description Senior/Principal Combination Product Design Quality Engineer (DQE)(Job Number: 200142)Description Senior/Principal Combination Product Design Quality Engineer (DQE)OverviewAlnylam is the world---s leading RNA interference (RNAi) company. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development. Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe---s Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine---s Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.The Senior/Principal Device Design Quality Engineer (DQE) ensures that Alnylam---s combination products are safe, effective, and usable, and are developed and brought to market in accordance with global regulatory requirements and standards. Working closely with Alnylam---s combination product development team, CMC teams, and external partners, the Senior/Principal DQE supports regulatory strategies and provides risk-based, collaborative quality oversight of design control and risk management deliverables. Throughout development phases, s/he supports all planning activities, human factors validation activities, design verification and testing activities, and design reviews, as well as regulatory filings. S/he provides quality oversight of combination product related suppliers and contract manufacturers. The Senior/Principal DQE provides technical quality support to sustaining engineering activities for in-clinic and on-market products, which includes design changes, market expansions, and risk reviews, as well as device-related exceptions, complaints, CAPAs, and change controls.Summary of Key ResponsibilitiesProduct Development:-- Provide guidance on combination product development and regulatory strategies to achieve program goals-- Proactively support design control activities as governed by project Design and Development Plan-- Provide product quality requirements and quality standards as design inputs-- Lead/support risk management planning, risk assessments, and reports-- Provide quality oversight of out-sourced human factors planning and studies-- Support design verification planning including in-house testing and developing risk-based sampling plans-- Support creation and maintenance of design outputs (e.g., specifications, DMR)-- Support design transfer activities, clinical-trial readiness, and launch preparation activities-- Provide quality oversight of external partners, including suppliers providing device components and contract manufacturers performing fill/finish and assembly operations-- Escalate significant quality risks or issues to senior leadership, and evaluate mitigation strategies-- Support regulatory filings, including submissions, meeting requests, and responses to questions-- Facilitate project updates and communications-- Support 10% domestic and international travelSustaining engineering:-- Support design-related continuous improvement efforts, design changes, and market expansions-- Provide technical (e.g., design focused) quality support for in-clinic and on-market products through supporting root cause investigations, complaint trending, CAPAs, and change controls-- Support post-market surveillance and risk management reviews-- Maintain risk management files throughout the product lifecycle-- Support internal audits, notified body audits, and regulatory inspectionsQualifications-- Bachelor---s degree in engineering or sciences. Advanced degree preferred.-- 5 to 10 years of device and/or combination product cGMP experience, including 5 years in a Design Quality Engineering/Assurance role-- Understanding of global Device and Combination Product regulations, standards, and guidelines (e.g. 21 CFR Part 4, Part 820, ISO 13485, ISO 14971, ISO 62366, ISO 11040, ISO 11608, ISO 23908, Medical Device Regulation) -- Extensive knowledge of global Design Control and Risk Management requirements and processes -- Experience in test lab equipment qualification and test method validation-- Working knowledge of statistics and six-sigma method methodology-- Experience leading Design Quality activities, and influencing cross-functional project teams and senior leadership-- Experience developing and commercializing different types of combination products (e.g., single entity, co-packaged, convenience kits, cross-labelled)-- Experience working with external partners for design, development, manufacturing, and testing-- Experience providing quality oversight of external partners (e.g., suppliers, CMOs, CTOs,), including conducting external audits and authoring quality agreements-- Experience providing general Quality Assurance support for an in-clinic or on-market product (e.g., device-related exceptions, complaints, CAPAs, change controls, risk management) -- Excellent organizational, communication, and interpersonal skills Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Keywords: Alnylam Pharmaceuticals, Somerville , Senior/Principal Combination Product Design Quality Engineer (DQE), Other , Somerville, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Parts Clerk
Description: Job Description Position Summary: Through their knowledge of the distribution industry, the Fleet team works to reduce costs, ensure compliance standards and assist locations with value added solutions (more...)
Company: Performance Food Group
Location: Taunton
Posted on: 01/17/2021

Business Lead
Description: As a leading regional provider of personal and commercial property and casualty insurance, The Concord Group helps protect what matters most-from the homes and cars that families rely on to the small (more...)
Company: Concord Group Insurance
Location: Concord
Posted on: 01/17/2021

COVID Contact Tracer (TEMP)
Description: Performs all tasks related to contract tracing of cases of COVID19 for the VNA contracted Towns on Cape Cod Accesses the MAVEN Massachusetts Virtual Epidemiologic network
Company: Cape Cod Healthcare Inc.
Location: Plymouth
Posted on: 01/17/2021


Shopper - grocery pros wanted for up to $22 an hour
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Salem
Posted on: 01/17/2021

Caliber Home Loans - Residential Underwriter - Mass
Description: Join a reputable mortgage company that offers a direct hire, six-figure income opportunity with full
Company: Caliber Home Loans
Location: Weymouth
Posted on: 01/17/2021

Packaging Representative
Description: Auto req ID: 261900BR br Job Summary FedEx Ground is an essential business that needs people to help us support the economy, handling life-saving medications and other items that keep our communities (more...)
Company: FedEx Ground
Location: Salem
Posted on: 01/17/2021

Santander Holdings USA Inc: Sr. Associate - Commercial Auto Dealership Underwriter
Description: Sr. Associate
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 01/17/2021

Packaging Professional
Description: Auto req ID: 261900BR br Job Summary FedEx Ground is an essential business that needs people to help us support the economy, handling life-saving medications and other items that keep our communities (more...)
Company: FedEx Ground
Location: Salem
Posted on: 01/17/2021

Loan Underwriter
Description: Join a reputable mortgage company that offers a direct hire, six-figure income opportunity with full
Company: Caliber Home Loans
Location: Salem
Posted on: 01/17/2021

Residential Loan Underwriter
Description: Job DescriptionJoin a reputable mortgage company that offers a direct hire, six-figure income opportunity
Company: Caliber Home Loans
Location: Salem
Posted on: 01/17/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Somerville RSS job feeds