Senior Staff Engineer, Combination Products and Devices

Position Summary:

The Senior Staff Engineer will serve as the project’s technical lead for the combination products and device development efforts leading to regulatory submissions and subsequent clinical and commercial use. The ideal candidate will be a hands-on and multi-disciplinary technical leader with a strong background in engineering drug delivery systems and drug-device combination products. The candidate will provide engineering leadership in all phases of drug-device combination product development and manufacturing while working with internal and external stakeholders.

Key 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.

Qualifications:

• 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.

The Following Additional Qualifications are a Plus:

• Previous experience in a technical leadership role for combination products.
• Design for Six Sigma knowledge/certification
• Experience in statistical analysis packages (Stat Ease, Minitab)
• Knowledge of adjacent functions such as Human Factors Engineering
• Knowledge of the latest development in the industry and provide key input into new device technology development.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.

Compensation

Target Salary Range: $168,588 - $206,052

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.