Manufacturing Engineer

HumCap's client, a company in the biomedical technology space, is searching for a Manufacturing Engineer to join their team.

• Plans, designs and analyzes manufacturing processes for devices and drug products.
• Owns technical aspects of new-product-introduction activities to transfer designs robustly into manufacturing.
• Determines equipment, tools, and processes needed to achieve manufacturing goals according to product specifications.
• Maximizes efficiency by optimization of layout of equipment, workflow, assembly methods, and work force utilization.

RESPONSIBILITIES

• Develop detailed layouts for equipment, manufacturing processes, and workflow.
• Evaluate existing manufacturing processes to identify areas for improvements.
• Research and develop new and/or improved processes, equipment, and products.
• Design, purchase, install, characterize, and validate manufacturing equipment, fixtures, specialty assembly tools.
• Develop, author, execute and document engineering investigations, process development studies, manufacturing work instructions, risk assessments, and validation protocols/reports (IQ, OQ, PQ).
• Process owner for nonconformances and CAPAs that arise from manufacturing issues.
• Own interactions with contract manufacturers and component suppliers for for issue resolution, component qualification, cost reduction and quality improvements.
• Partner with Research to evaluate designs for manufacturability prior to production.
• Preferred: Implement graphic arts designs and controlled content on finished product labels and packaging.

QUALIFICATIONS

Experience and Education

Experience :

· Bachelor’s degree in engineering, preferably Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field required.

· Minimum 5 years’ experience in medical devices, including a minimum of 3 years supporting active manufacturing operations under strict quality-system controls.

· Experience in contract manufacturing required.

· Experience with manual and semi-automated assembly processes for electromechanical devices required.

· Familiar with processes for sterilization, bioburden, and endotoxin testing.

· Experienced with design transfer / new product introduction; has borne significant responsibilities in successful launch of at least one product, ideally orthopedic.

· Experienced in requirements development, design-change analysis, risk management, and change-control procedures.

· Understanding of GxP, FDA Quality System Regulations, ISO 13485, and ISO 14971.

Skills and Abilities

Excellent organizational and communication skills.

· Ability to prioritize tasks and manage multiple projects effectively.

· Demonstrates entrepreneurial spirit; able to thrive and contribute impactfully in an agile startup environment.

· Hands-on, driven work ethic, with high attention to detail, and high ownership approach to process/product quality.

· Ability to communicate complex technical data in format appropriate to support critical decision-making activities; excellent presentation skills and technical writing ability.

· Solid grasp of statistical methods applicable to process development, investigations, and validation.

· Able to engage effectively with peers and project colleagues at contract manufacturing organizations, and with suppliers.

Computer Software / Programs

Required proficiencies:

· Microsoft Office

· Google Suite

· SolidWorks or comparable CAD software

· Minitab or comparable statistics software

Desired proficiencies:

· SmartSheet project management software

· Python programming language

· Graphic-art software (e.g., Adobe Illustrator)

· Commercial label-generation software (e.g., Bartender, Nicelabel, Labelview)