Engineering Services Manager

Job Description
Paramit is a rapidly growing international medical device contract design and manufacturing company that has been designing and manufacturing high quality medical and life sciences instruments. Headquartered in Morgan Hill, CA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for a dynamic Engineering Services manager (Document Control manager ) to join us as the leader of our high performing Engineering Services team.
This position is responsible for leading, establishing, and maintaining a configuration management system capable of meeting regulatory, quality, and company requirements for documentation in a medical device design and manufacturing environment. This position manages departmental resources, leads company initiatives, establishes configuration management policies and procedures, and provides engineering services to the company.
Essential Duties and Responsibilities:
Manage customer interaction to download the product data package including BOM, drawings, and facilitate BOM scrub for quote as well as upload in Manex ERP system
The main contact for issues related to the ERP system and upgrades. Provides guidance and advice on methods, procedures, standardization, and requirements.
Establish and maintain a configuration management system compliant with regulatory, quality, company, and customer (both internal and external) requirements.
Responsible for document change control. Control design changes will include, but not limited to product BOM, CAD drawings, PCBA documentation, test results, ECOs, customer communication, and deviations.
Regulates the change process so that only approved and validated changes are incorporated into released product documentation.
Ensures accuracy by reviewing documents for completeness, proper authorization, and system updates.
Collaborate with cross-functional departments to ensure timely implementation of change requests and change orders (ECR/ECO's).
Support audits (internal, external, 3rd party) in order to verify that regulatory and quality requirements have been met.
Responsible for procedure reviews and facilitating procedure updates with process owners.
Assure that all company personnel are adequately trained in the principals, policies, and procedures of the configuration management system.
Required Education & Experience:
o Associates degree or equivalent combination of education and experience.
o 3+ years configuration management/document control experience.
o 3+ years of prior supervisory or management experience in an EMS/CM environment.
Required Knowledge, Skills & Abilities:
o Understanding of the fundamentals of configuration management.
o Knowledge of drawing and drafting using computer aided drawing software.
o Good written and verbal communications skills.
o Strong organizational skills and ability to review/update processes/procedures.
o Knowledge of electronic record and electronic signature requirements.
o Strong MS Office Suite experience (i.e. Word protected forms and Excel macros, etc.)
o Experience with SQL Query tools (MS Query, etc.)
Good system integration and project management skills.
Experience with other ERP systems.
Knowledge of medical device regulations (21CFR820, ISO 13485, IEC 62304, ISO 14979, CMDR, JPAL, MDD, 2007/47/EC).
Knowledge of Valor DFM
Knowledge of PCB layout requirements

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