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

Alexion Pharmaceuticals; Boston (MA); Híbrido; USD 102 000 - 152 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Incentives program

Equity-based awards

Health, dental and vision coverage

Resumo da oferta

Alexion Pharmaceuticals is seeking an Engineer III for device development to support design activities for device and combination products. The role offers a hybrid work pattern with in-office collaboration three days a week in Boston, MA or travel to New Haven, CT as needed.

You will work with engineering and partner teams to drive design verification, mold/fixture development, and quality/compliance activities under IQ/OQ/PQ validation.

Qualificações

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical).
• Experience in design control activities.
• Knowledge of primary containers and drug delivery.
• Understanding of mold, fixture design and validation (IQ/OQ/PQ).
• Experience with medical device vendor collaboration.
• Regulatory requirements: FDA QSR 21 CFR Part 4 and ISO13485.
• Office-based role with strong communication and problem solving.
• 4–6 years in medical device development preferred.
• Injector-based combination product experience preferred.

Responsabilidades

• Support device development activities with the engineering team to bring a combination product to market.
• Collaborate with device partners on design verification and hardware development.
• Assist in container closure system evaluation and development.
• Characterize device function, assembly and manufacturability using CAE and physical testing.
• Test electromechanical systems on bench models and production-representative units.
• Liaise with third-party manufacturers and tooling suppliers.
• Communicate effectively across departments and with suppliers.
• Align with QA and regulatory requirements for device design controls.

Conhecimentos

Device development experience

Regulatory compliance knowledge

Vendor collaboration

Problem solving

Formação académica

Bachelor's degree in Engineering

Ferramentas

IQ/OQ/PQ validation

Descrição da oferta de emprego

Alexion Pharmaceuticals is seeking an Engineer III for device development to support design activities for device and combination products. The role offers a hybrid work pattern with in-office collaboration three days a week in Boston, MA or travel to New Haven, CT as needed.

You will work with engineering and partner teams to drive design verification, mold/fixture development, and quality/compliance activities under IQ/OQ/PQ validation.