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Upstream Bio · 1 hour ago

Senior Staff Engineer, Combination Products and Devices

Waltham, MA

Full-time

Onsite

Senior Level, Lead/Staff

$169K/yr - $206K/yr

9+ years exp

Upstream Bio is a public company based in Waltham, MA, focused on developing innovative treatments for severe asthma and other conditions. They are seeking a Senior Staff Engineer to lead technical efforts in the development of combination products and devices, ensuring regulatory compliance and collaboration with various stakeholders.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Provide technical leadership to the combination product core team while managing the activities of external partners and internal stakeholders around design and process development to support clinical and commercial regulatory registrations as well as ongoing support for manufacturing, release and stability

Use technical expertise and engineering rigor to lead all technical project execution activities and assume overall ownership of user needs, design input requirements, design documentation, test development, biocompatibility, design verification and validation (V&V) testing and process development and validation for the project

Ensure a traceable flow from requirements to design, V&V and control strategy while collaborating closely with other technical functions such as drug product formulation, analytical development, packaging/labeling and human factors among others

Lead Risk Management activities such as Hazard Analyses, FMEA, etc. for design and manufacturing

Work with the project manager and program lead to formulate and maintain the project plan and schedule

Assume ownership of appropriate quality documentation and provide support around quality systems

Establish strong collaborative relationships and demonstrate ability to influence internal and external design/development partners, manufacturing partners and service providers

Mentor and coach other members on the team regarding technical development of medical devices and combination products

Perform all other duties as assigned

Qualification

Medical device developmentDrug delivery systemsRegulatory submissions21 CFR 820 complianceISO 13485 knowledgeDesign for Six SigmaStatistical analysisHuman Factors EngineeringEffective communicationCollaboration skills

Required

Degree in engineering with a minimum of 9 years of experience in Class II or Class III medical device development

A minimum of 5 years of experience in developing drug delivery and combination products such as pre-filled syringes, auto-injectors or on-body devices

Proficiency in working with drug development and manufacturing teams to ensure smooth interactions at the transition points

Proficient in managing external stakeholders and vendors

Extensive working knowledge and application of 21 CFR 820/Part 4, EU MDR, ISO 14971, ISO-13485 and other standards as well as drug cGMPs as they relate to the design and manufacture of medical devices and combination products

Must be able to communicate and collaborate effectively at all levels, both verbally and in writing

Must be able to work with ambiguity and use good judgement in making decisions

Must be able to travel around 20% of the time