Our medical technologies firm in Mahwah, NJ is looking for an Engineer.
Create surgical planning template drawings from existing CAD models and possibility troubleshoot CAD models to enable drawing creation. Populate design control documents to hold design reviews and launch templates into the market.
- Designs, validates and brings new products to market.
- Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety.
- Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials.
- Creates design control documents to complete a design history file.
- Collaborates with internal manufacturing partners and contract manufacturers to optimize designs for manufacturability.
- Partner with Marketing and Regulatory to meet user and regulatory body needs.
- Utilizes Pro Engineer Creo (CAD) to model new designs and produce detailed engineering drawings.
- This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
- Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
- Job requires an understanding and application of procedures and concepts of own discipline.
- The job requires attention to detail in making evaluative judgements based on the analysis of factual information.
- This job typically requires a Mechanical Engineering degree or equivalent and a minimum of 2 or more years experience.
- MS, CQE, or CRE. Six Sigma Green or Black belt.
- 5+ years directly relevant experience in manufacturing or quality role in a medical device manufacturing company working with electro-mechanical components.
- Familiarity with and understanding of US and International Medical Device Regulation, ISO 13485, GDP, GMP, etc. Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- Strong communication, project management and influencing skills as well as ability to manage multiple tasks simultaneously.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently and as part of cross-functional teams, sometime in high pressure situations.
- Ability to represent Quality function with project teams.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong critical and "outside the box" thinking. Highly developed problem solving skills and analytical skills.
- Computer literacy.
We put our Ambassadors first. When it comes down to it, we know we can't fulfill our Promise to our business customers without your commitment. You represent our organization while on assignment. In return, we do our best to show our commitment to you. Our Ambassador Benefits package includes: Medical, dental and vision coverage. It also includes 401k, sick time, holiday and much more. We are an equal opportunity employer.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disabili