About this vacancy:
An exciting opportunity for a dedicated and results-oriented Design Engineer with proven experience managing projects with all stakeholders, clients, internal departments, and outside vendors. He/she will design medical devices from customer specifications or internal needs according to ISO13485 – FDA 21 CFR part 820.30 and/or CE mark standards, while creating, and maintaining the Design History File (DHF). He/she will work closely with engineering to design, minimize production costs, and sustain a competitive advantage in the medical device industry (instrumentation, devices, implants). This role is based in Wisconsin (between Milwaukee and North Chicago) and reports directly to the R&D Manager.
The Design Engineer designs, and manages new product development from concept to production, coordinating with sales, clients, marketing, engineering, prototyping, quality, and manufacturing functions. He/she defines the Design File containing rationale for choice, design, and materials, requested technology, drawings, process flowchart, and risk management. The Design Engineer quotes client’s projects where needed, following all R&D procedures, and formalize the input data provided by the R&D Manager. He/she defines targets and lead-times for project tasks with project team, evaluates and optimizes the overall project planning till SOP.
Established 20 years ago in Europe, Intech is an international leader in the development and manufacturing of Orthopedic and Spine surgical instrumentation & implants, w/production facilities in Europe, Asia and North America. Intech employs over 900 skilled and dedicated specialists across the world including more than 200 at this production site.
Essential Duties and Responsibilities:
- Develop, design, and manage new product development from concept to production, coordinating with sales, clients, marketing, engineering, prototyping, quality, and manufacturing functions.
- Evaluate material selection to implement new designs. Review the selection and specification of new purchased component parts for product designs.
- Manage projects, providing technical assistance to sales/marketing, including travel to customers, samples, and project estimates.
- Manage project schedule, budget, and resources to successful project conclusion. Report progress of all aspects to R&D Manager.
- Organize and Manage meetings with stakeholders involved in the project to carry out reviews of design in accordance with the process: preliminary design, critical design, and design transfer.
- Define targets and lead-times. Evaluate and optimize the overall project planning till SOP.
- Negotiate with clients and relevant departments internally (sales, marketing, R&D, testing, prototyping, manufacturing) both technical and schedule aspects to match client’s needs in term of performance and planning.
- Complete project deliverables. Identify levers for go/no go decisions and incorporates them into a project plan, typically focusing on projects with higher impact.
- Elaborate the design history file from design input to design verification, including risk analysis, preliminary engineering calculations, stack-up verifications, tests specifications and design verification matrix, in conformance with the ISO 13485, FDA 21 CFR part 820 requirements, and CE Mark 2017/745.
- Participate at the survey of intellectual property. May lead brainstorming for intellectual property. Review legal agreements and submit IP disclosures.
- Submit “3D” model of concept for validation to Management or Clients, justifying the design choices, based on the specifications.
- Ensure development of prints and create tolerance analysis of components and devices.
- Assist at Test Protocols, report, and lab notebooks. Specify and review the testing of new designs, interpret test data, recommend, and implement necessary corrective actions.
- Review and evaluate returned products, analyze root cause failures and disposition of materials.
- Participate in process improvement projects to continually improve the cost efficiency of design and manufacturing processes. Make cost effective design decisions.
- Accountable for design accuracy, functionality, quality and on time completion.
- Manage design reviews and transfer reviews to support Manufacturing/Quality Engineers on analyzing designs to determine the availability of machinery and equipment, control plan and determine if customer specifications are suitable for production (Critical Design Reviews).
- Oversee the manufacturing of the prototype to include, in drawings, the elements to facilitate manufacture of pre-series or series.
- Train new employees, when needed, following R&D Manager directions.
- Be informed about company quality engagements, quality strategy and quality annual targets.
- Respect quality principles and rules as per FDA “21CFR” and ISO 13485 standards.
- Suggest to possible innovations and answers to clients’ questions about improvements of existing products.
- Be informed about innovations related to company products & markets, through reports & scientific papers.
- Based on experience and skills, can be identified as referent of a specific technology, tool, product, customer in global R&D
- Bachelor’s Degree in Engineering (Mechanics, Mechatronics, Biomedical) preferred or proven experience in similar industry would be considered. PMP certification a plus.
- 5-7 years’ related experience in product development engineering within a machining production and design facility. Medical devices experience preferred.
- Ability to design and develop innovative medical devices that meet required regulations and market demands.
- Proficient with project planning; ability to effectively manage new product development process through the production phase and conducting tests to validate products.
- Thorough understanding of raw materials, manufacturing processes, capabilities, and quality control practices.
- Knowledge of mechanical parts processes and capabilities, incl. manufacturing, assembly, and molding.
- Advanced knowledge and understanding of blueprints and GD&T.
- Proven knowledge and experience working with AutoCAD and
- Experience in ISO/FDA environment and understanding of medical device regulations per ISO 13485 and FDA Part 801, 803, 820, 821, CE mark (MDR 2017/745).
- Ability to understand the technical attributes of a wide range of precision, mechanical products.
- Ability to identify complex problems and review related information to develop and evaluate options and implement solutions for appropriate course of action.
- Strong problem solving, critical thinking and analytical skills.
- Ability to work in a team environment, as well as autonomously.
- Ability to communicate effectively in multi-discipline, cross cultural environment, at all levels of organization.
- Capable of handling stressful situations.
- Excellent verbal and written communication skills.
- Detail oriented and organizational skills.
- Ability to maintain a sense of urgency and ability to prioritize workload.
- Ability to effectively manage multiple projects at a time.
- Computer literate in various software applications (Microsoft Office).
- Experience with content management/quality systems, archiving and control techniques.
- Competitive salary compensation
- Healthcare generous package (Medical, Dental, Vision)
- General plan (401K match, S-T/L-T disability, Life insurance)
- Relocation package