Position Summary :
The Operations Manager is a dynamic, challenging, and high impact role that reports directly to senior leadership. Integral to all aspects of the business, the Operations Manager is a functional leadership position that leads and contributes to project teams, manages production planning and resource allocations, supports manufacturing assemblers and technicians, and tracks key performance indicators (KPIs).
Essential Duties and Responsibilities :
- Ensures compliance to ISO 13485 and 21 CFR 820 in manufacturing operations
- Serves as the program manager for manufacturing and New Product Introduction (NPI) related programs
- Develops assembly processes and product inspection or test processes, including custom fixtures / tooling / gauges
- Manages and executes process validations
- Contributes to Risk Management efforts including Process Failure Mode and Effect Analysis
- Supports NPI and Design Transfer activities
- Assists with build planning and inventory management
- Ensures the accuracy and completeness of documents and records for inclusion in DHFs / DHRs
- Collaborates on compliant and efficient strategies for reaching customer milestones
- Participates in Material Review Board activities and provides disposition recommendations for nonconforming inventory
- Leads root cause investigations and participates in the CAPA process
- Tracks KPIs and reports performance to senior leadership
- Provides mentorship and leadership to other manufacturing personnel
- Establishes personnel development plans and holds periodic performance reviews with direct reports
Required Education, Experience, Skills and Knowledge :
- Minimum 7 years of professional experience
- Medical Device experience required
- Manufacturing support experience required
- Product development or NPI experience required
- Bachelor’s Degree in Engineering or Technical Field desired
- Prior leadership experience preferred
- Well versed in ISO 13485 and 21 CFR 820
- Strong understanding of statistical methods and sampling plans
- Excellent aptitude and confidence in customer facing communications
- Detail oriented, organized, and diligent in record keeping and Good Documentation Practices (GDP)
- Willing to learn and grow within the organization
- Customer focused with excellent communications skills, written and oral
Salary Range :
$96,000 to $141,000 (25th percentile / 90th percentile, PayScale data); Bonus eligible depending on achieving company performance targets.
Benefits :
This position will be eligible to enroll in benefits including health, dental and vision programs as well as AD&D and Long-Term Disability Insurance, 401(k).
Position will accrue 15 PTO days per year and 1 additional day for each year of service (up to 25 days).
Apply to : [email protected]
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