Careers

FEATURED JOB OPPORTUNITIES

Manufacturing Engineer Lead

Tewksbury, MA.

The Manufacturing Engineer Lead is responsible for the planning, development, validation, execution, and improvement of manufacturing processes. Maximizes efficiency by planning and implementing a lean workflow with assembly methods that continually improve work force utilization and product quality. Working as a member of a project team consisting of R & D, Quality, Clinical and Regulatory Affairs, the Manufacturing Engineer Lead plays a key role in the development and release of new products to manufacturing. This position will also require trouble shooting and resolution to component and process issues that arise.

Primary Responsibilities

  • • Participates in R&D project teams in support of design and development activities that contribute to successful transition to manufacturing using Design for Manufacturability concepts.
  • • Interacts daily with the manufacturing teams providing hands-on support, troubleshooting, and improvement opportunities for manufacturing processes and equipment.
  • • Collaborate with internal resources to develop technical solutions to difficult problems that are thorough, practical, and consistent with organization objectives and often documented on Corrective Action and Preventive Action (CAPA) reports.
  • • Defines and performs equipment installation, manufacturing process characterization, capability studies, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as process/test method validation for manufacturing equipment and processes.
  • • Identifies and implements GMP’s (good manufacturing practices) that apply to specific production area(s) and providing training as needed to ensure production team understands and can complete assembly procedures while following GMP’s.
  • • Applies Six Sigma and Lean tools to solve production problems and to improve existing processes.
  • • Provides work direction to Product or Process technicians as required.

Supervisory Responsibilities

• Responsible for the oversight of Associate Process Engineer and Associate Test Engineer

Education Requirements

Bachelor's degree in an engineering discipline.

Experience

  • • Minimum 5 years of medical device manufacturing related experience, preferably catheter and implantable experience.
  • • GMP’s and Six Sigma/Lean Manufacturing techniques and tools.
  • • Manufacturing process qualification (IQ/OQ/PQ), software validation, and process/test method validation.
  • • Project management participation or leadership (preferred) from concept though implementation.
  • • Wide application of technical principles, theories, and concepts for manufacturing.

Knowledge

  • • Knowledge and experience with Six Sigma and Lean Manufacturing techniques and tools preferably with a minimum of Green Belt level of certification.
  • • Deep knowledge of the regulatory and compliance requirements of device design controls and combination products. (i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements).

Skills

  • • Possesses strong engineering and analytical skills.
  • • Strong data analysis skills, and proficient in the use of statistical tools in problem solving.
  • • Demonstrated interpersonal and leadership skills with ability to interface well with other departments in a team environment.
  • • Possesses strong communication skills (verbal & written) and the ability to coordinate cross-functionally with R&D, Quality, Operations, Clinical, and Marketing.
  • • Strong computer skills (MS Outlook, Word, Excel & Project), & CAD (SolidWorks) experience required.
  • • Possesses the ability to be able to build product as required

Physical Demands and Conditions Requirements

  • • General office environment.
  • • Potential for domestic and international travel up to 15%.

Equipment Used

  • General office, respective laboratory, and device manufacturing equipment.

Job Type

Full-Time

Required education:

  • Bachelor's degree in an engineering discipline.
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Regulatory Affairs Specialist

Tewksbury, MA.

The Regulatory Affairs Specialist will provide worldwide regulatory affairs support for Class III medical devices. The Regulatory Affairs Specialist is responsible for activities that lead to, and maintain regulatory approval for these medical devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of these device changes.

Primary Responsibilities

  • • Prepare global regulatory submissions such as EU Design Dossiers, IDE, PMA submissions and supplements.
  • • In collaboration with Director, develop global regulatory strategies to seek approvals for new and modified devices worldwide.
  • • Obtain and maintain registration of assigned products in rest of world markets
  • • Provide regulatory support to currently marketed products, as necessary. Assesses product and manufacturing changes for compliance with applicable regulations and prepare submissions and reports as required by classification and geography.
  • • Review device labeling, advertising, sales support and training materials for compliance with submissions and applicable regulations.
  • • Provide regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes.
  • • Provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis.
  • • Provide regulatory input to the company for compliance with ISO and FDA Quality System Regulation requirements.
  • • Provide input for clinical studies to assure compliance with domestic and international regulatory requirements (GCP)
  • • Assist Director in negotiations with the FDA or other regulatory agencies for assigned projects.
  • • Perform Regulatory intelligence and notify organization of updated information regarding worldwide laws, guidelines, and standards.
  • • Other duties, as assigned.

Supervisory Responsibilities

• None

Education Requirements

Bachelor's Degree with a minimum of 2-years regulatory affairs or a minimum of 1-year regulatory affairs with Master’s Degree

Experience

  • • History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
  • • Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

Knowledge

  • • Regulatory Affairs Certification (RAC) preferred, but not required

Skills

  • • Excellent organizational, multitasking, and communication skills
  • • Proficiency with MS Office Suite and Adobe Acrobat Professional

Physical Demands and Conditions Requirements

  • • General office environment.
  • • Potential for domestic and international travel up to 15%.

Equipment Used

  • General office, respective laboratory, and device manufacturing equipment.

Job Type

Full-Time

Required education:

  • Bachelor's Degree with a minimum of 2-years regulatory affairs or a minimum of 1-year regulatory affairs with Master’s Degree
Apply

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Mitralign, Inc.

This site may contain information on worldwide products, not all of which are available in every location. A reference to a product on this site does not imply that such product is or will be available in your location. The products referred to on this site may be subject to different regulatory requirements depending on the country of use. Consequently, visitors may be notified that certain sections of this site are intended only for health care professionals in certain countries. For the availability of a particular product in your country, please contact the company directly.