Careers

FEATURED JOB OPPORTUNITIES

Process Engineer

Tewksbury, MA

The Process Engineer 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 Process Engineer 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

None

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

Related quality experience in the medical device industry:

  • 5 Years
Apply

Quality Manager

Tewskbury, MA

The Quality Manager leads the development and maintenance of company’s quality systems including CAPA’s, deviations, and document/change control. Serves as quality team member for product development teams. Responsible for the design and implementation of policies and procedures to ensure that quality standards are met for the organization and the full lifecycle of the devices. Responsible for compliance functions including the Quality Assurance laboratory and respective incoming, in process, and lot qualification testing.

Primary Responsibilities

  • Coordinate the reporting, analysis, and resolution of material non-conformance incidences.
  • Participate in Design Review meetings.
  • Develop quality assurance specifications, test methods, sampling plans and related written procedures.
  • Coordinate the identification, assignment, monitoring, and completion of product improvement projects.
  • Qualify and implement Document Changes Notices involving product or process changes.
  • Assist Regulatory Affairs Department in preparation of regulatory submissions and interface with the FDA or other regulatory agencies in case of on-site audits.
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
  • Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Research and Development functions.
  • Provide support in the rapid resolution of product complaints and/or safety issues.
  • Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Research and Development functions to coordinate pilot production of new products.
  • Provide support to product development teams by developing test plans.

Supervisory Responsibilities

Team of quality engineers, technicians, laboratory associates.

Education Requirements

BS in life sciences, engineering, or equivalent preferred.

Experience

  • Medical Device experience, preferably Class II or III, in an ISO-registered company, preferably ISO 13485, GMP.
  • Minimum five years related quality experience in the medical device industry

Knowledge

  • Deep understanding of ISO 13485 and its implementation and maintenance requirements.
  • Knowledge and experience with Six Sigma and Lean Manufacturing techniques and tools a plus.
  • Understanding of regulatory requirements associated with health and medical technologies.

Skills

  • Very good verbal and written communication skills.
  • Computer skills: Working knowledge of MS Word, Excel, Access, and PowerPoint.
  • Ability to work without direct supervision with a sense of urgency to meet projects goals and customer expectations.
  • Must be energetic with a good attitude and be versatile in the areas of Quality Assurance, Engineering, R&D, and Manufacturing preferably in a small company.
  • Ability to take direction and pursue goals with minimal supervision.

Physical Demands and Conditions Requirements

  • General office environment.

Equipment Used

  • General office equipment.

Job Type

Full-time

Required education:

  • Bachelor's

Related quality experience in the medical device industry:

  • 5 years
Apply

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Mitralign, Inc.

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