Engineering Manager (Manufacturing)

Location: Juncos, Puerto Rico, United States of America

Company

hirify.global develops medical technologies focused on alleviating pain, restoring health, and extending life.

What you will do

• Lead manufacturing engineering functions supporting production process development, validation, implementation, and continuous improvement.
• Drive process robustness, equipment performance, automation projects, product transfers, and process validations including IQ/OQ/PQ.
• Lead Lean Manufacturing, Six Sigma, productivity improvement, and cost reduction initiatives.
• Support CAPA and nonconformance investigations while optimizing manufacturing systems for quality, efficiency, and compliance.
• Direct the development of medical device products and related processes from initial design through market release.
• Lead engineering personnel and coordinate activities with suppliers, consultants, and cross-functional stakeholders.

Requirements

• Requires a bachelor's degree in engineering and at least 5 years of relevant experience, or an advanced degree and at least 3 years of relevant experience.
• Experience leading manufacturing engineering in a regulated manufacturing environment.
• Expertise in Lean Manufacturing, Six Sigma, continuous improvement, process validation, equipment qualification, and technology transfers.
• Knowledge of FDA regulations, GMP, ISO 13485, CAPA, root cause analysis, SPC, FMEA, DOE, and process optimization.
• Ability to manage engineering teams and cross-functional projects with strong communication and stakeholder management skills.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is offered only for Principal-level roles and above.

Culture & Benefits

• Purpose-driven work developing technologies that improve patient health.
• Competitive compensation and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Reasonable accommodations are available for qualified individuals with disabilities.