Impel’s product development team is a technical, driven, highly collaborative group focused on introducing the best products possible into the market. As an engineer within this group, you will contribute to the development process by focusing on engineering project management, supplier development, and process validation to effectively translate designs into products.
The product development engineer is responsible for developing project plans, monitoring and mitigating risks, and reporting functional execution to keep projects on schedule and address issues and bottlenecks before they become problems. Excellent communication skills are required as the role will provide a conduit between the internal and external development resources.
The ideal candidate has a positive attitude, shows perseverance in problem solving, and is passionate about developing new medical therapies. You must be a self-starter and be willing to roll up your sleeves to find a solution to any problem.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
- With technical staff input, develop comprehensive project plans to be shared with staff and suppliers
- Own functional management and tracking of development activities at external, global, contract manufacturing organizations and component suppliers
- Interface with internal cross functional team to ensure all requirements are correctly translated to supplier
- Outstanding communications skills, keeping both the engineering function and cross functional team up to speed on progress and challenges. The ability to generate quality reports/design documentation is essential
- Develop and improve departmental project management tools and approaches
- Participate in the development of process validation at assembly CMOs and component suppliers
- Meet budgetary objectives and make adjustments to project constraints based on financial analysis
- Ability to collaborate within a team environment as well as execute independently on project tasks
- Support design verification testing as required
- Support product manufacturing through the transfer to operations
- Must be capable of continuous learning and have a desire to take on an ever-changing list of tasks.
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s degree is required in mechanical engineering or similar field – mechanical aptitude required
- Minimum 5 years of experience as a member of a product development team
- Track record of successfully developing supplier capabilities
- Experience in medical device or pharmaceutical industry
- Experience validating manufacturing processes
- Multi-task and drive multiple projects forward in parallel
- Must be proficient in Microsoft Office products
- Outstanding communication skills
- Positive team player, willing to step in and fill identified project team gaps
- Previous experience with contract manufacturing
- Previous experience commercializing new products
- Management experience
- Supply chain management
- Project management professional certification
- Injection molding experience
- Design verification testing experience
Must be capable of lifting packages under 50 lbs. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines
This is a fast-paced environment with moderate noise level.
Up to 30% travel is anticipated.