Senior Engineer Manufacturing

• Provide technical expertise and support to manufacturing teams for 10-12 medical device manufacturing assembly lines, troubleshooting and resolving production issues
• Develop and maintain manufacturing process documentation through the Engineering Change Management (ECM) process
• Conduct root cause analysis and implement corrective actions to address process deviations and equipment failures
• Develop and execute Process and Equipment Validation/Verification Strategies for new or changing manufacturing process elements
• Develop and execute Engineering Builds and assist with Material Qualification Planning to support new or changing component requirements
• Perform and document Impact Assessments and Corrective Actions for Equipment Remediation’s associated with out of tolerance calibration results
• Analyze and improve manufacturing processes to enhance efficiency, reduce waste, and increase productivity
• Develop and implement process control strategies to ensure consistent product quality and compliance with regulatory standards
• Lead and manage engineering projects from conception through implementation, ensuring they are completed on time and within budget
• Collaborate with cross-functional teams to align project goals with business objectives
• Prepare and maintain accurate documentation related to manufacturing processes
• Guarantee alignment with all relevant safety regulations, industry standards, and company policies
• Identify and implement continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance manufacturing performance
• Monitor key performance indicators (KPIs) and develop action plans to achieve operational goals
• Mentor and train junior engineers and manufacturing staff on best practices, process improvements, and new technologies
• Perform other duties as assigned by management to support the overall goals of the quality team
• Proactively contributes to zero harm in the workplace by always following legal and corporate Environmental Health & Safety requirements
• Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm
• Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training
• Ensure that all testing activities comply with relevant regulatory standards and quality management systems
• Report any safety concerns or incidents to management in a timely and accurate manner

• Bachelor’s degree in mechanical engineering, Industrial Engineering, Manufacturing Engineering, or a related field
• a master’s degree is preferred
• Minimum of 3-7 years of experience in manufacturing engineering or a related field, preferably in a regulated industry such as medical devices or pharmaceuticals
• Proven experience in project management and process improvement initiatives
• Experience in the Medical Device or a similar regulated industry is preferred
• Strong knowledge of manufacturing processes, equipment, and technologies
• Excellent analytical and problem-solving skills, with the ability to work under pressure
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• OSHA certification (e.g., 30-hour or 40-hour), Other certifications (e.g., biomedical engineering, electrical engineering) and Lean Six Sigma certification or equivalent
• Must be able to sit for long periods of time
• Must have good hand to eye coordination and dexterity
• Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time
• Applicants must be authorized to work for any employer in the U.S.

PLC & CNC programming experience is a plus.

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits