Manager, Manufacturing Endovascular - Merrimack, NH

Job Overview

Manages manufacturing activities to meet organizational objectives for schedule achievement, cost management, quality, safety and efficiency for all manufacturing operations while ensuring compliance with safety, state and federal regulations.

Job Responsibilities and Essential Duties

• Manages manufacturing operations meeting quality, productivity, scrap, cost effectiveness and housekeeping.
• Manages manufacturing operational standards by monitoring capacity, productivity, schedule achievement and quality performance, implementing corrective actions.
• Manages manufacturing financial standards by monitoring costs; implementing corrective actions.
• Continuously improves by assessing manufacturing and business processes for efficiency improvement, benchmarked against best industry practices.
• Collaborates with Engineering, Quality and staff members to analyze and resolve major process and quality issues.
• Provides leadership in selecting, developing and evaluating personnel to ensure the efficient operation of the manufacturing floor.
• Manages departmental staffing needs and adjusts accordingly to ensure optimized flexible trained workforce.
• Directly supervises manufacturing supervisors and/or team leaders/group leaders.
• Participates in all scheduled product/process development meetings.
• Maintains compliance with all regulatory standards for product and personnel safety.
• Represents the company during FDA inspections.
• Provide necessary information to FDA that demonstrates compliance with cGMP's.
• Maintains safe and healthy work environment by following and enforcing standards and procedures; complying with legal regulations.
• Contributes to team effort by accomplishing related results as needed.

Minimum Requirements

• Bachelor's degree (Operations Management, Engineering or other technical discipline) or equivalent work experience.
• A minimum of seven years Operation Management and/or Manufacturing Experience, preferably in a medical device environment.
• Knowledge of Oracle a plus.

Required Knowledge, Skills and Abilities

• Experience in implementation and sustainability of Lean Manufacturing concepts.
• Proven leadership skills creating an engaged associate environment.
• Ability to manage multiple priorities in a manufacturing plant setting.
• Flexible and adaptable to changing circumstances, procedures, and environment.
• Working knowledge of Quality Systems Regulation (QSR) requirements for medical devices.
• Demonstrated business ethics, integrity and discretion required.
• Strong computer skills, including MS Office (Word/Excel) applications.

Supervision/Management of Others

• Ability to coach, develop and motivate associates.
• Ability to optimize team effectiveness.
• Abilityto impact team morale, sense of belonging, and participation.
• Responsible for development of team and accountability to hire, fire or discipline.

Internal and External Contacts / Relationships

• Internal:
  
  
  
  • Quality Engineering / Manufacturing Enigneering / Regulatory / Various others
  
  
  
  
• External:
  
  
  
  • Material suppliers / Equipment suppliesr / SME resources / Various others
  
  
  
  

Quality Requirements

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Office or production environment
• May work extended hours during peak business cycles.
• Physical requirements such as lifting a specified weight on a regular basis, standing for a period of time
• Travel requirements

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Salary:

• Salary Range: $120K - $145K DOE

#LI-DV1