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FEATURED JOB OPPORTUNITIES

Research and Development Engineer

Tewksbury, MA

Design, develop and update cardiac implants and delivery catheters for treatment of cardiac valve insufficiency. Position includes support of multiple development projects or primary management of a development project of moderate scope with guidance from management as needed. As a Project Leader, the engineer would also serve as the primary technical contributor through manufacturing onload.

Primary Responsibilities

  • Develop catheters, handles, implants and other medical devices within the EN 13485 compliant design control process
  • If assigned a device project, manage and maintain primary leadership of assigned project through the design control process from concept through manufacturing transfer to product commercialization
  • Create and manage timelines for projects through full range of assigned responsibility.
  • Proactively communicate program progress, risks and recommendations to management as appropriate
  • Develop and document thorough and accurate specifications for devices, components and materials
  • Develop test methods, create written procedures and as needed perform product testing
  • Develop robust manufacturing processes and create written procedures
  • Perform or oversee conceptualization, design, documentation and fabrication of fixturing for test and assembly
  • Develop, build and iterate product prototypes
  • Provide routine verbal updates to management and written reports of work
  • Develop engineering experiments with guidance as needed, execute, analyze and document to guide product and process development
  • Propose vendors or develop assigned vendors and serve as primary interface within all phases of product development including prototyping, development and initial production
  • Operate within Mitralign procedures and industry standards for product development and manufacture
  • Maintain laboratory notebooks to document work activities
  • Participate in clinical activities including observing medical procedures and interfacing with clinicians
  • Participate in animal studies related to development work
  • Participate in patent related activities related to development work
  • Participate in production build and QC inspections activities as needed
  • In addition to the essential functions listed above, other responsibilities and key result areas as assigned

Supervisory Responsibilities

Engineering technician or intern.

Education Requirements

BS degree in engineering (Biomedical, plastics, mechanical or similar)

Experience

  • Minimum of 3 years of hands-on experience in an engineering position, preferably in the medical device field
  • Experience with management of a project timeline
  • CAD experience recommended (preferably SolidWorks)

Knowledge

  • Good mechanical aptitude
  • Practical understanding of general materials properties, stress/strain, kinematics/dynamics
  • Understanding of polymeric materials and metals and their properties
  • Understanding of primary and secondary processes commonly used in catheter assembly, including injection molding, extrusion, melt and adhesive bonding and machining
  • Must have working knowledge of ISO 13485 and FDA Quality System Regulations

Skills

  • Team player possessing a high level of ethics and professional integrity
  • Ability to produce prototypes and test units in an engineering lab environment
  • Ability and personality to manage projects in a fast-paced small company environment
  • Ability to learn and work within regulatory requirements associated with medical technologies
  • Excellent verbal & written communication skills applied within the company and with vendors and consultants
  • Must be able to work independently and be self-motivated

Physical Demands and Conditions Requirements

  • General office and engineering lab environment.

Equipment Used

  • General office equipment.
  • Hand tools and machine tools

Job Type

Full Time

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Associate Process Engineer

Tewksbury, MA

The Associate Process Engineer is responsible for the validation, execution, and improvement of manufacturing processes. Maximizes efficiency by 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 Associate 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 project teams in support of 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
  • Perform or assist with 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
  • Support GMP’s (good manufacturing practices) that apply to specific production area(s) to ensure production team understands and can complete assembly procedures while following GMP’s
  • Provide work direction to Product or Process technicians as required
  • Applies Six Sigma and Lean tools to solve production problems and to improve existing processes

Education Requirements

Bachelor's degree in an engineering discipline or equivalent

Experience

  • Minimum 2 years of medical device manufacturing related experience, preferably catheter and implantable experience. Recent college graduates with internship experience will also be considered
  • GMP’s and Six Sigma/Lean Manufacturing techniques and tools preferred
  • Performing manufacturing process qualification (IQ/OQ/PQ), Software Validation, and Process/Test Method Validation
  • Wide application of technical principles, theories, and concepts for manufacturing
  • Project management participation from concept though implementation

Knowledge

  • Six Sigma and Lean Manufacturing techniques and tools at a Green Belt level of certification a plus
  • 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 analytical skills
  • Strong data analysis skills, and proficient in the use of statistical tools in problem solving
  • Demonstrated interpersonal 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:

  • Medical Devices: 2 years
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Senior Quality Manager

Tewskbury, MA

The Senior 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

  • Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
  • Provide expertise and guidance in interpreting and applying governmental regulations, agency guidelines and internal policies to assure compliance as it pertains to Quality Operations practices
  • Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions
  • 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
  • Collaborate with Regulatory Affairs Department in preparation of regulatory submissions.
  • Oversee internal audits and external audits from various regulatory agencies 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
  • Actively participate on new product development projects ensuring that product design inputs are clear, concise, testable and appropriate, and that design outputs confirm compliance to the design inputs
  • Provide support to product development teams by developing test plans
  • Other miscellaneous responsibilities as required

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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