Employment


Available Positions

Senior Design Engineer

REQUIRED BACKGROUND

7-10 years experience in designing surgical instruments in the fields of cardiology, cardiovascular surgery, endoscopy, laparoscopy, and orthopedics. Knowledge of catheter based products and mechanical disposable devices are desirable.

RESPONSIBILITIES

Design and develop instruments for a wide variety of device OEMs Communicate with customers and surgeons to understand clinical requirements.

Define design parameters.

Ensure the correct product is provided to the customer.

POSITION REQUIREMENTS

Ensure compliance with FDA regulations, and support 510(k) submissions or IDE clinical studies.

Create and maintain project plans and FDA compliant Design History Files.

Develop appropriate mechanical and functional test protocols.

Coordinate the activities required to fabricate test parts and complete design testing.

Work in conjunction with manufacturing during the design stages of product designs.

Responsible for all designs from concept development through product launch.

Perform bench-top development, prototyping, modeling and testing.

Strong communication and interpersonal skills.

Ability to interact with various customers and surgeons.

Experience in the creation of solid models (SolidWorks), analyzing designs (COSMOS) and detailed drawings for new designs, maintain design control documentation and project files adhering to FDA and ISO design control requirements.

EDUCATION

Bachelor’s degree in Mechanical or Biomedical Engineering required.

Quality Engineer

REQUIRED BACKGROUND

3-5 years’ experience in Quality Engineering for a regulated industry (prefer medical devices) in the fields of cardiology, cardiovascular, endoscopy, laparoscopy, and orthopedics.

POSITION REQUIREMENTS

Ensure company compliance with ISO and FDA regulations,
Review and approve DHR, DMR and FMEA for FDA compliance requirements.
Work in conjunction with operations team for the release of finished product.
Work in conjunction with engineering team for product development activities.
Strong communication and interpersonal skills.
Ability to interact with various departments within the company.
Preferred experience in design control documentation and project files adhering to FDA, ISO 13485 and 14971 requirements.

EDUCATION

Bachelor’s degree in Mechanical or Biomedical Engineering preferred.

POSITION REQUIREMENTS

  1. Bachelor’s Degree in Engineering, Science or equivalent (5 years in relevant experience)
  2. Minimum of 3-5 years’ experience as a Quality Engineer
  3. Experience with functioning in a highly-regulated environment with working knowledge of ISO 13485 and FDA QSR requirements
  4. Ability and motivation to work on own initiatives.
  5. Strong written and verbal communication skills.
  6. Background in leading root cause investigations and implementing effective corrective/ preventive actions (CAPA)
  7. Process development capabilities skills; analytical problem solving including Minitab software experience.
  8. Certified Quality Auditor by ASQ.
  9. Handling of controlled documents.
  10. Supplier Quality Engineering for incoming components, initial qualification and on-going monitoring.
  11. Proficient in MS software including Word, Excel, PPT.
  12. Experience and proficiency with statistical tools including but not limited to the following:
    • Data Analysis
    • Risk Analysis
    • Root Cause Analysis
    • Statistical Method Application
    • Capability Studies
    • Gage R&R Studies
    • Probability

Apply Now

Please send a pdf of your resume.

info@interplexmedical.com