Device Development Engineer III — Hybrid (Boston/New Haven)

Alexion Pharmaceuticals, Inc.; Boston (MA); Hybrid; USD 102.000 - 152.000; Vollzeit

Zusammenfassung

Alexion Pharmaceuticals, Inc. is seeking an Engineer III for device development to advance Johnsen products and continuous improvements within the Development function.

The role supports technical design and development activities for device and combination products and aids technology transfer. The position is hybrid (Boston, MA 3x/week) or New Haven, CT, with a base salary band of $101,643 to $152,465 and eligibility for incentives and benefits.

Qualifikationen

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical) required.
• 4-6 years experience in medical device development preferred.
• Experience with device design controls and combination products regulatory requirements.
• Understanding of mold, fixture design, and validation processes (IQ/OQ/PQ).
• Experience collaborating with device vendors and tooling companies.

Aufgaben

• Support device development activities with the engineering team for combination products.
• Collaborate with device partners on design verification and tooling for drug delivery devices.
• Assess and develop innovative container closure systems.
• Characterize device function and manufacturability using CAE and traditional methods.
• Test mechanical/electromechanical systems on bench and production units.
• Coordinate with third-party manufacturers and toolmakers.
• Communicate effectively with internal teams and external suppliers.
• Align with QA and regulatory requirements.

Kenntnisse

Design control activities

Drug delivery knowledge

Regulatory knowledge (FDA QSR/ISO13485

Ausbildung

Bachelor’s degree in Engineering

Jobbeschreibung

Alexion Pharmaceuticals, Inc. is seeking an Engineer III for device development to advance Johnsen products and continuous improvements within the Development function.

The role supports technical design and development activities for device and combination products and aids technology transfer. The position is hybrid (Boston, MA 3x/week) or New Haven, CT, with a base salary band of $101,643 to $152,465 and eligibility for incentives and benefits.