The Sr Mechanical Engineer will work collaboratively with a team to design and develop medical products from initial concept through the transfer to production. The engineer will have a technical leadership role for designing and testing components and subassemblies of the overall system product. The job requires excellent CAD skills, design of plastic injection molded parts and machined metal components, development and execution of tests for evaluation and verification. Expertise in design of sheet metal enclosures is desired. The engineer should have broad knowledge of plastic and metal materials and be able to define the selection criteria and tradeoffs for different materials. Skills for thermal or structural analysis as well as statistical analysis are needed.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
- Act as a technical lead for product development projects. Provide mentoring and guidance to other team members.
- Manage the overall development of parts and subassemblies for a project design. Interact with Clinical and Marketing departments to determine design requirements and goals.
- Outline and execute to short-term goals to achieve overall project milestones.
- Conceive, design, build, and evaluate prototypes to explore a range of design concepts.
- Prepare, present, and document designs at technical reviews.
- Refine and develop selected concept(s) with little guidance from manager.
- Investigate and evaluate materials, adhesives, and assembly techniques based product requirements and based on past experience.
- Select vendors for prototypes, request quotes and prepare purchase requisitions. Provide recommendations for production vendors.
- Use best methods of design for manufacture and assembly (DFMA) and document the DFMA benefits of the chosen design.
- Plan, perform, and document verification testing. Coordinate testing by other team members,
- Help develop assembly procedures and assist in transfer methods to manufacturing.
- Document ECO changes within the Document Control system.
- Coordinate design tasks for other team members for complex product designs.
- Coordinate design constraints within ME team and other R&D groups. Resolve any design conflicts with preferably no managerial intervention.
Products under development are likely to include:
- Injection molded plastic parts, mechanical layout of flex circuits, elastomeric components, machined or sheet metal fabricated components (including brazed or welded components), films, electrical connectors and cables use of force, and temperature sensors, design of seals for fluid systems
• BS in Mechanical Engineering or equivalent degree. Advanced degree desirable.
• Must have at least eight years of product design and development experience; prefer ten years of experience.
• Prefer at least three years of experience in medical devices, ideally class II devices.
• Must be proficient with 3D CAD modeling; prefer Pro/E Wildfire/Creo experience or SolidWorks. Needs some CAD analysis skills for thermals and structures.
• Must be familiar with the capabilities and limitations of a variety of fabrication techniques (e.g. plastic injection molding, vacuum and pressure forming, sheet metal, stamping, machining).
• Individual will complete work with minimal supervision of the manager. Will typically be the technical leader.
• Proficient with basic standard concepts and constraints involved in creating new product designs. Should be knowledgeable of new modern methods for making prototype or production parts.
• Ability to set medium term project goals and outline schedules for multiple tasks for several team members.
• Strong team player with the demonstrated abilities and willingness to wear “multiple hats” and perform a wide range of tasks within a dynamic environment.
• Individual must have strong verbal and written communication skills.
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
Language and Verbal Skills:
Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals in English. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in complicated, advanced engineering or mathematical formats.
Analytical and Reading Skills:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to analyze a variety of technical instructions in mathematical or diagram form and interpret various abstract and concrete variables. Ability to read technical and clinical literature and documents and extract important concepts.
The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; typically for 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate. Typically the employee will need to spend about 40 hours per week to complete assigned tasks but that may increase during critical project times. Most work will be done on site to facilitate the collaborative nature of the product development process.
Requires some presence in a (clinical or engineering or animal) laboratory setting where protective equipment or other health and safety measures and training are required to protect against chemical, biological or other hazards.. Short duration domestic travel may be required quarterly or semi-annually to visit vendors or customer sites. Limited international travel may be required.
Allergan/Zeltiq is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.