Senior Engineer , Device Development

Position: Senior Engineer I, Device Development
Location:

Boston, MA or New Haven, CT

This is what you will do:

This position will serve the role of Development Engineer within the Alexion Device Development organization. The candidate will act as the technical SME/project engineer supporting the development of combination products. This role will be accountable for key technical design and development deliverables. This individual will interact with multiple functions and functional teams including Device Quality, Regulatory Affairs, Clinical, Global Technical Operations (GTO), and Alexion Dublin Manufacturing Facility (ADMF) from clinical development through commercial development.

You will be responsible for:

Deep understanding of the device design: this may include development/ identification of critical dimensions, systems engineering, sensitivity analysis, tolerance stack-ups. Technical assessments to be conducted via analytical and empirical means. Devices of interest include: pre-filled syringes, autoinjectors, pen injectors, and on-body delivery systems.

Based on understanding of device design, manage facets of technical development. This can include interactions with suppliers, CMOs, technology vendors and/or internal cross-functional teams.

Oversee the characterization and design verification testing as well as determine relevant success criteria. This includes development, qualification, and the transfer of the appropriate methods.

Author technical documentation in support of the development process or design control deliverables.

Root Cause analysis of product or process deviations or failures. Utilization of six sigma tools to manage the investigation.

Ability to clearly communicate learnings and educate other team members on methods and analytical approaches.

Acts independently within team expectations, coordinates with functional leadership to identify priorities, completes tasks under his/her accountability while balancing a high level of autonomy .

Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation.

Demonstrate strong and clear accountability/responsibility for successful and timely completion of designated tasks.

You will need to have:

BS Degree (Mechanical, Biomedical, Chemical Engineering or Materials Science and Engineering) or closely related disciplines

6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries or related experience (experience with combination products, specifically prefilled syringes, autoinjectors, pen injectors, and on-body injectors preferred).

Experience with developing products or implementing product changes through a structured, phase-gated, product development process.

Demonstrated experience with all phases of the Design Control process.

Demonstrated experience in a technical, product development role on a cross-functional team, leadership role preferred.

Understanding of medical device product development risk management methodologies.

Possesses expertise in statistical analysis (Minitab, Crystal Ball, etc), analytical tools (e.g. FEA), benchtop testing (e.g. Zwick, fixture design) and experience in root cause analysis/investigation

Strong team building and collaboration skills across the organization. Possesses intellectual curiosity to deeply understand technical concepts.

Knowledge of performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820 / ISO
13485 quality system requirements).

The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

Master's, or PhD Degree in Engineering (Mechanical, Biomedical, Chemical or Materials Science and…