Manager, Manufacturing Engineering

Responsibilities

• Support production and ensure the continuity of manufacturing operations.
• Drive root cause analysis for non-conformance, long-term corrective actions, and preventive measures.
• Evaluate and correct systemic issues.
• Work with Manufacturing and Maintenance personnel to improve performance of manufacturing systems, i.e. yield improvements, scrap reduction, MUV reduction, cycle time improvements, ergonomic issues and maintenance needs.
• Spearhead initiatives for continuous process and lean implementations.
• Assess yield issues and promote design and/or selection of equipment to reduce costs and improve quality.
• Manage all stages of multiple engineering projects.
• Promote attainment of organizational objectives through team members.
• Provide leadership and guidance for non-routine problems requiring substantial judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criteria.
• Work with vendors and internal departments to obtain necessary resources, resolve inter-departmental issues and contribute toward organizational objectives.
• Provide direct management to a team of Engineers/Engineering staff, determine priorities based on business needs and resource availability.
• Conduct project/team meetings to resolve issues, determine current status, provide information and assess changes in priorities.
• Oversee preparation of documentation associated with engineering activities to include drawings/schematics, validation/capability testing, various new and revised operating procedures.
• Generate timelines and milestones to bring projects to completion on time and within budget.
• Model company values and support strategic initiatives.

Qualifications

• Successfully completed numerous new product launches and product design changes to in the medical device field.
• Demonstrated working knowledge of supplier controls, process validation, failure investigation techniques, root cause analysis, corrective/preventive action procedures, and protocol/report generation.
• Understanding of ISO 13485 requirements, medical device validations, and regulatory requirements.
• Computer Skills (Microsoft Word, Excel, Project, PowerPoint, PLM system, CAD).
• Superb Oral and Written communication skills including presentation skills.
• Ability to work in a team/partnership environment.
• Black Belt/Green Belt certification or Lean Six Sigma experience desired.
• Language fluency in English and Spanish.
• Experience: Six-Sigma Methodology (DOE, Process Capability, Gage R&R etc.). Lean Methodology to drive equipment and processing improvements/production efficiency. Knowledge of Solid Works and experience with ASME Y14.5, ISO and GD&T standards.
• Maintain thorough understanding of the clinical use/risk of the product.
• Thorough understanding of strength of materials, kinematics and dynamics, vibration, and fluid flow, as well as automation, plastic injection molding, part assembly, fixturing, testing and process control techniques.
• Knowledge of the Medical Device Industry and familiarity with associated regulations.
• Excellent problem solving and analytical ability.
• Education: Bachelor’s Degree in Engineering or Technology. 5 years of experience in Medical Device Engineering/Technology 3-5 years management experience Strong injection molding, tooling and automation background preferred.

Benefits

• Outstanding total compensation plan.
• Medical coverage.
• 401(k).
• Parenthood leave.
• Fertility benefits.
• Paid time off for vacation, personal, sick and holidays.
• Multiple other perks and benefits.