What are the responsibilities and job description for the Technical Director for Medical device manufacturer position at Multi Radiance Medical?
Job Description
The Technical Director (TD) at Multi Radiance Medical, medical device company has a multi-faceted role with responsibilities and authority that spans several top-level disciplines: IT, Quality Assurance, Regulatory Affairs, Engineering, and Operations. TD is a highly collaborative role, managing projects with direct reports as well as cooperative work across verticals. Above all, the TD is a root cause analyst and high-level problem solver across disciplines.
Quality Assurance
Assist in implementation and maintenance of Quality Management System (QMS), that complies with ISO 13485, ISO 14971 and applicable national and international regulations
Assist in development, administration and keep up of quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
Support the quality inspection to ensure projects, products and processes comply with the relevant requirements of the QMS.
Assist in creating and maintaining of company quality documentation, such as manuals, procedures, etc.
Maintain and implement Risk Based Approach model
Regulatory
Oversee implementation of EU MDR requirements on the SOP level
Co-liasion (with RA Manager) with 3rd party Regulatory Consultants (multiple)
Primary assist on medical device clearances (FDA, MDD, MDR, Health Canada) as Subject Matter Expert
IT
Administrate MS Office 365
Administrate web-hosting services
Administrate Quickbooks Enterprise (local) server and backups
Administrate OneDrive (Projects, QMS, etc.)
Administrate phone/fax services
In-house liaison to 3rd party IT services
Operations
Analyze failure, corrective and preventive action to respond to internal/external customer complaints
Continuously improve QA processes and procedures
Monitor all operations that affect quality
Assure the reliability and consistency of production by checking processes and final output
Assist in developing new SOPs and WIs
Managing Customer Service process, according appropriate SOPs
Advise on Inventory and Purchasing with particular emphasis on top-level organization amongst multiple verticals
Engineering
Oversee creation and maintenance of MDFs for medical devices.
Oversee creation and maintenance of DMRs, including Assembly Instructions, Testing Instructions, etc.
Managing manufacturing process, according to DMR instructions.
Responsible for complaint investigation and long-term corrective actions.
General
Root cause analysis and implementation of corrective action for product and process related concerns.
Vendor management: technical suppliers, contract manufacturers, development partners
Work Experience Requirements
Work experience in medical device field is a plus.
Ability to handle many tasks at once including heavy phone and email volume
Ability to provide clear instructions in an educational format; written and didactic.
Must possess good interpersonal skills with a customer service-oriented attitude
Advanced computer skills required, including but not limited to:
Advanced knowledge of measurement equipment (electrical, optical)
Ability to follow through and resolve issues
Ability to work independently with minimal supervision
Prior team management required
Bilingual: Russian/English required
Education Requirements
BS/BA degree in engineering field or equivalent experience
Advanced Degree/experience Preferred
Project Management Certificate beneficial
Physical Requirements
Occasional travel (up to 10%)
Occasional lifting up to 55bs., and pushing/pulling up 26 lbs
Daily (5 days/week) travel into office in Solon, OH
Company Description
We are the leading developer and marketer of non-invasive laser therapy, electrotherapy medical device technology. Rapidly growing company with expansion in pain management, rehabilitation,chiropractic, sports medicine, veterinary and podiatry fields. We are growing and adding members to our corporate team.
We are the leading developer and marketer of non-invasive laser therapy, electrotherapy medical device technology. Rapidly growing company with expansion in pain management, rehabilitation,chiropractic, sports medicine, veterinary and podiatry fields. We are growing and adding members to our corporate team.
The Technical Director (TD) at Multi Radiance Medical, medical device company has a multi-faceted role with responsibilities and authority that spans several top-level disciplines: IT, Quality Assurance, Regulatory Affairs, Engineering, and Operations. TD is a highly collaborative role, managing projects with direct reports as well as cooperative work across verticals. Above all, the TD is a root cause analyst and high-level problem solver across disciplines.
Quality Assurance
Assist in implementation and maintenance of Quality Management System (QMS), that complies with ISO 13485, ISO 14971 and applicable national and international regulations
Assist in development, administration and keep up of quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
Support the quality inspection to ensure projects, products and processes comply with the relevant requirements of the QMS.
Assist in creating and maintaining of company quality documentation, such as manuals, procedures, etc.
Maintain and implement Risk Based Approach model
Regulatory
Oversee implementation of EU MDR requirements on the SOP level
Co-liasion (with RA Manager) with 3rd party Regulatory Consultants (multiple)
Primary assist on medical device clearances (FDA, MDD, MDR, Health Canada) as Subject Matter Expert
IT
Administrate MS Office 365
Administrate web-hosting services
Administrate Quickbooks Enterprise (local) server and backups
Administrate OneDrive (Projects, QMS, etc.)
Administrate phone/fax services
In-house liaison to 3rd party IT services
Operations
Analyze failure, corrective and preventive action to respond to internal/external customer complaints
Continuously improve QA processes and procedures
Monitor all operations that affect quality
Assure the reliability and consistency of production by checking processes and final output
Assist in developing new SOPs and WIs
Managing Customer Service process, according appropriate SOPs
Advise on Inventory and Purchasing with particular emphasis on top-level organization amongst multiple verticals
Engineering
Oversee creation and maintenance of MDFs for medical devices.
Oversee creation and maintenance of DMRs, including Assembly Instructions, Testing Instructions, etc.
Managing manufacturing process, according to DMR instructions.
Responsible for complaint investigation and long-term corrective actions.
General
Root cause analysis and implementation of corrective action for product and process related concerns.
Vendor management: technical suppliers, contract manufacturers, development partners
Work Experience Requirements
Work experience in medical device field is a plus.
Ability to handle many tasks at once including heavy phone and email volume
Ability to provide clear instructions in an educational format; written and didactic.
Must possess good interpersonal skills with a customer service-oriented attitude
Advanced computer skills required, including but not limited to:
- Knowledge of basic computer networks and components required
- Knowledge of all Microsoft office applications required
- Mastery of video conferencing tools (Zoom, Teams, etc.) using multiple devices simultaneously
- Python/C#/VBA proficiency (read and some edit/write)
Advanced knowledge of measurement equipment (electrical, optical)
Ability to follow through and resolve issues
Ability to work independently with minimal supervision
Prior team management required
Bilingual: Russian/English required
Education Requirements
BS/BA degree in engineering field or equivalent experience
Advanced Degree/experience Preferred
Project Management Certificate beneficial
Physical Requirements
Occasional travel (up to 10%)
Occasional lifting up to 55bs., and pushing/pulling up 26 lbs
Daily (5 days/week) travel into office in Solon, OH
Company Description
We are the leading developer and marketer of non-invasive laser therapy, electrotherapy medical device technology. Rapidly growing company with expansion in pain management, rehabilitation,chiropractic, sports medicine, veterinary and podiatry fields. We are growing and adding members to our corporate team.
We are the leading developer and marketer of non-invasive laser therapy, electrotherapy medical device technology. Rapidly growing company with expansion in pain management, rehabilitation,chiropractic, sports medicine, veterinary and podiatry fields. We are growing and adding members to our corporate team.