Valeant Pharmaceuticals

Senior Mechanical Design Engineer

Job Location US-MO-St Louis
Job ID
9859
Pos. Category
R&D

Overview

Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The Senior Mechanical Design Engineer, R&D is expected to be an experienced individual contributor of mechanical design expertise for R&D projects in a medical device company. The Senior Mechanical Design Engineer applies a broad knowledge of engineering principals to design new surgical equipment and handheld devices for ophthalmic surgery. He or she provides comprehensive product development services from conceptual design to product release. He or she approves modifications to existing designs, assesses acceptability of non-conforming parts, and troubleshoots product complaints in a team setting. The Senior Mechanical Design Engineer may also provide project coordination and technical/project leadership for select accessory development activities.

 

Key Relationships

Internal: Commercial, Operations, Design Quality, R&D Project Management, Regulatory Affairs

External: Surgeons/Key Opinion Leaders (KOLs), Nurses, Clinical Staff, Outside Technical Support Agencies

Responsibilities

The Senior Mechanical Design Engineer shall be an individual contributor and technical project lead for New Product Development (NPD) projects. The primary scope of development activities supported by position shall be Class I and Class II, Ophthalmic Surgical Equipment and Accessory Devices for both Anterior and Posterior Segment Indications. Additional design change support to facilitate maintenance of business (MOB) shall be provided as required based on the mix of projects in the pipeline or as appropriate based on subject matter expertise. Infrequent work assignments at the O’Fallon, MO manufacturing site may be required to achieve specific NPD and MOB objectives. Responsibilities include: 

  • Leads new product development activities and performs design-related tasks.
  • Generates design concepts for new products based on marketing inputs.
  • Collaborates with personnel from marketing, manufacturing, and quality to ensure that new designs meet customer requirements.
  • Prepares documentation to ensure that product development processes comply with FDA accepted control guidelines.
  • Creates 3D Autodesk Inventor/Solid Works models and 2D prototype drawings for parts and assemblies.
  • Optimizes performance of products using FEA/CFD software tools.
  • Assists R&D technicians in assembling new devices.
  • Evaluates new prototypes against performance criteria and solicits feedback from marketing product managers.
  • Attends surgical procedures and communicates with clinical advisors to acquire customer feedback for new products.
  • Prepares detailed specifications for and participates in small scale production of new product designs.
  • Writes test protocols, performs experiments, and authors reports to support new product verification efforts.
  • Participates in validation of new products and documents results.
  • Reviews and approves design changes and verification plans for released products and procedural packs.
  • Performs comprehensive engineering activities to support new product development projects.
  • Provides consulting support for product improvement and maintenance of business projects.

Qualifications

Required Education:  BS in Mechanical Engineering

Preferred Education: MS in Mechanical Engineering or other Advanced Technical/Scientific Degree.

 

Required Skills/Qualifications:

  • Ability to create electro-mechanical designs using Solid Works, AutoCAD, Autodesk Inventor, or equivalent software.  
  • Proficiency using one or more FEA/CFD software tools. 
  • Ability to interpret and create engineering drawings, specifications, reports, and other engineering or manufacturing documentation.
  • Strong knowledge of electro-mechanical systems, devices, and materials including pneumatic systems, fluidic management systems, and ultrasonic energy delivery systems.
  • Broad knowledge of manufacturing methods (Machining, Injection Molding, Etc.). 
  • Expertise in mechanical design and tolerance analysis. 
  • Expertise with instrumentation and test equipment/software. 
  • Working knowledge of electrical systems. 
  • Good working knowledge of MS Office tools, analytical tools, project management tools, ERP systems. 
  • Excellent oral and written communication skills. 
  • Demonstrated ability to work cross-functionally.

Preferred Skills/Qualifications:

  • Multi-disciplinary product design for ultrasonic energy transmission. 
  • Application experience with PZT ceramic materials. 
  • Acoustic analysis/finite element analysis (FEA). 
  • Computational Fluid Dynamic Analysis (CFD). 
  • Electro-mechanical, medical equipment design. 
  • Medical device design control and risk management expertise.

Required Experience:

  • BS with Minimum of 5 years of experience, MS/PhD with a minimum 3 years experience involving medical device development and manufacturing in a GMP environment per ISO 13485 and CFR 821.  Alternatively, 5 or more years of new product development experience involving mechanical/electro-mechanical equipment involving application of pneumatic and/or ultrasonic energy.

Preferred Experience: 

  • 7 or more years of product development design/project leadership experience involving design control, verification and validation testing, and risk management for electro-mechanical medical devices. 
  • Demonstrated history of innovation demonstrated by patents and successful product introductions.

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

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