Project Engineer

Description:

• Seeking a Systems Engineer to join their Device and Combination Product Development team within R&D.
• This individual will contribute to the development of innovative devices and therapeutic combination products across various phases of clinical studies, and will work closely with cross-functional colleagues in operations as programs transition to commercial development
• As a Systems Engineer with a primary focus on Use-Related Risk Analysis (URRA), you will be responsible for coordinating and driving the successful completion of use-related risk analyses for drug products and associated delivery systems - including on-body devices, pre-filled syringes, autoinjectors, mixing devices, and complex electromechanical pumps.
• You will integrate inputs and risks from multiple disciplines to ensure robust, patient-centric product design and performance, while partnering closely with cross-functional stakeholders across human factors, quality, clinical, medical safety, development, and manufacturing teams.
• Working alongside a global team of scientists, engineers, and leaders, your expertise and leadership will ensure that all systems are safe, effective, and aligned with applicable internal procedures, regulatory expectations, and quality standards - for both clinical and commercial development programs.
• You will be responsible for implementing holistic systems engineering principles within the Design Controls process, with a PRIMARY focus on Use-Related Risk Analysis (URRA) and additional focus on Design Inputs, Risk Management, Traceability, Systems Integration, and DHF architecture.
• Lead planning and coordination of creating use-related risk analysis activities across all assigned programs.
• Facilitate cross-functional meetings to drive development of use-related risk analyses, ensuring team members provide timely inputs for which they are responsible.
• Partner with functional experts - including human factors, quality, clinical, medical safety, development, and manufacturing - to support accurate documentation of hazards, use scenarios, failure modes (i.e., use errors), risks, and mitigations.
• Monitor progress against milestones and proactively escalate risks, delays, and unresolved issues to appropriate stakeholders.
• Support team development and review of URRA documentation to ensure delivery of inspection-ready records to the URRA owner.
• Drive consistency in URRA process execution and continuously identify opportunities for process improvement.
• Systems Engineering Responsibilities
• In support of the broader systems engineering framework, you will support the following activities and deliverables:
• System Architecture & Integration
• User and Stakeholder Needs Definition
• Use Case Analysis
• Standards Coverage Analysis
• Product Requirements Definition
• Traceability
• Risk Management planning and reporting
• System Risk Assessment
• Use-Related Risk Assessments, Design FMEAs, and Process FMEAs
• Change Management
• Oversight and integration of Third-Party Development activities
• Integration of Design Control and Quality by Design (QbD) activities

Qualifications:

• BS in Engineering, Science, or a closely related discipline with 5+ years of relevant experience; or MS with 3+ years of experience.
• 3-5 years of experience specifically in pharmaceutical, medical device, combination product, or other regulated industry environments preferred.
• Demonstrated scientific writing skills and strong verbal communication skills.
• Ability to multitask effectively and deliver results within established timelines.
• Demonstrated ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Expertise in end-to-end product development from initial concept through market release, with direct experience in combination product or medical device development; familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred.
• Expertise in Systems Engineering principles including user and stakeholder need definition, requirements definition, risk management, product architecture, configuration management, traceability, and change management.
• Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
• Working knowledge of use-related risk analysis, human factors, and risk management methodologies.
• Strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization and manage competing priorities.
• Strong analytical and decision-making skills; self-driven and proactive in approach.
• Experience creating and managing project schedules and identifying project risks and mitigation plans.
• Proficiency with project tracking and document management tools.
• Experience interfacing with third-party vendors, including communication management, deliverable acceptance testing, and multi-cultural awareness.

Preferred Experience

• Experience supporting drug product and delivery system development.
• Familiarity with relevant human factors and risk management regulatory expectations.
• Ability to synthesize complex technical input into clear, actionable plans and documentation.
• Demonstrated proactive, collaborative approach in a fast-paced, highly matrixed environment.
• Experience in vendor communication, management, and deliverable acceptance testing.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.