Wi is a medical device product development company specializing in the design and engineering of medical devices. Wi provides world class medical device development services at competitive rates.

For job descriptions please refer to links above.

Send your resume to mcollins@wiinc.net

Send your resume' to mcollins@wiinc.net

Senior Mechanical Engineer

Position Description:

Wi is a developer of state-of-the-art diagnostics medical devices and a leading-edge developer of life-saving diagnostic products. The position supports new product development by executing engineering tasks and collaborating cross functionally to bring new drug delivery systems into a production environment. This position plays a crucial role in the development of a rapidly growing engineering operation with responsibility for projects in engineering, including device and machine design, process development, verification / validation testing and document control.

The key function of this position is to provide hands-on development and overall engineering support for customer product development and commercialization of medical surgical, disposable and diagnostic devices. Medical device and injection molded product development skills are essential.

Responsibilities :

• Primary responsibility will be process and device design development, and validation for production of medical devices
• Actively participate in all phases of the product development process, from idea creation through to transfer to manufacture
• Assist in defining product requirements, communicate and resolve technical issues, and create and present project reviews and updates

Effectively collaborate with cross-functional team members comprised of quality, manufacturing, marketing, clinical, regulatory, and materials people to bring product from conception to production

Develop preproduction quality assurance processes used during new product development projects and design changes to existing products

Capable of mentoring fellow co-workers with less experience

Experience/Qualification Requirements:

BSME and 5+ years of relevant design engineering experience or 8+ years of equivalent design engineering experience

Experience with design and fabrication of small feature devices and knowledge of plastics, materials and various plastic bonding techniques

Able to take designs from concept to detail prints

Working knowledge of Machine Shop, Plastic Fabricators and Sheet Metal Shop practices including rapid prototyping, machined and injection molded parts

Familiarity with developing and maintaining document control procedures

Excellent communication skills with the ability to interface with clients

Familiar with engineering laboratory equipment, test methodologies and standards

Tolerance analysis and structural analysis using CAD and FEA software, respectively is preferred

Experience in performing FMEA's , verifications and validations for medical devices products and processes a plus

Experience in a medical product development and design environment a big plus

This is a hands-on position and you must be currently and actively engaged in product development and have the ability to work effectively with small product design teams of 2 to 10 people

Software Requirements:

4-6+ years expertise with SolidWorks, including experience with surfacing techniques and advanced modeling and drafting or equivalent 3D modeling software and drafting

Mold Flow a plus

Experience with MatLab and Labview a plus

Knowledge of Microsoft Office at an Intermediate or higher level

Send your resume' to mcollins@wiinc.net

Engineering Development Manager

Position Description

Wi is a developer of state-of-the-art diagnostics medical devices and a leading-edge developer of life-saving diagnostic products. The position supports new product development by executing engineering tasks and collaborating cross functionally to bring new drug delivery systems into a production environment. This position plays a crucial role in the development of a rapidly growing engineering operation with responsibility for projects in engineering, including device and machine design, process development, verification / validation testing and document control.

The key function of this position is to provide hands-on leadership and management for customer product development and commercialization of medical surgical, disposable and diagnostic devices. Medical device product development experience and skills are essential.

Responsibilities:

• Development and manufacturing implementation of medical surgical and diagnostic devices from concept to production.
• Responsible for technical development of products and management of development partners and customers
• Assist and/or own technical organization, definition, design, processes and documents as they relate to product engineering and manufacturing products.
• Own technical and development supplier management activities in areas of design, manufacturing and quality
• Assist via proactive and completion oriented methods the project specifications, contingency plans, schedule, budget, issues and priorities.
• Proactively manage customer relationship and expectations
• Identify and communicate project risks and solutions to manager
• Attempt to remove obstacles and escalate accordingly to manager.
• Manage technical development of engineering products via process development, specification creation, engineering design/rigor, prototype development, test, debug, introduction to manufacturing, and sustaining.
• Spearhead assigned special projects within the development/manufacturing of products.

Qualifications and Experience

• A successful track record in positions related to development of medical devices requiring mechanical, electrical, software, optical engineering and manufacturing.
• Significant technical product development and supplier management experience.
• 5+ years and College or University Degree or 8+ years of applicable experience
• Solid demonstration of technical project management and/or lead design experience in one or more of the following disciplines as they relate to a small consumer or medical device: mechanical, electrical, software, optical, micro-fluidics
• Cross functional competence with an ability to work a balance between customers, suppliers, engineering, and operations.
• A good understanding of engineering phase and development processes.
• Ability to identify and manage risk.
• Ability to improve project efficiencies and predictability.
• Familiarity in computer/consumer/medical surgical or IVD systems development.
• Experience in product manufacturing, maintenance and support.
• Strong multitasking capability and contingency planning skills
• Track record in product delivery by means of scheduled and tracked project with multi technical disciplined product.
• Experience related to designing, prototyping, testing and debugging consumer or commercial devices
• Some exposure to high volume manufacturing
• Familiarity with engineering design and test tools for development such as FEA, tolerance analysis, FMEA's, ECAD, EMI, Shock&Vibration, signal analysis, Zemax

Personal Characteristics

• Effectively operates within ambiguous and dynamic situations.
• Proactive, self-starter, requiring little direction
• Engages contributors across all functional disciplines with positive interpersonal skills. Listens attentively.
• Delivers to expectations and establishes effective relationships.
• Capable of thinking "out of the box" with imagination and creativity while relentlessly maintaining the plan.
• Works enthusiastically with a strong results orientation.
• Willing to take a stand, make decisions and move on in a fast paced environment.
• Loves to make a difference within a winning team.
• Balances high personal ambition with a good sense of humor.
• Places high value on personal integrity and trust.