The Product Development Engineer (Staff Engineer) shall operate under the direction from engineering management with minimal supervision, working from formal market requirements or generally stated objectives. This position is accountable for directed aspects of engineering for new product development, from initial product conceptualization through engineering development and pilot run to production implementation. There will also be responsibility for engineering support of current products through continuous improvement or quality enhancement projects, solving customer related or production needs and cost reduction efforts. The Product Development Engineer shall ensure the IRRAS products can be manufactured and marketed to the highest standards, are in alignment with the overall goals of the company, its brand expectations and contribution margin.
To be successful, this person must be a highly effective project team member ensuring adherence to master plans, schedules, and budgets while using technical knowledge gained through experience to launch and improve high quality medical device related products.
- Assists Marketing via participation in development of the market research data.
- Research new product and competitive product testing and evaluation.
- Participate in activities required for product certification by industry standards and regulatory agencies.
- Generates creative ideas for new products and/or improvements to current products.
- Prepares complex design layouts and/or sketches for new product designs and design improvements to existing product lines.
- Accountable for the technical accuracy and quality of work, including analytical analysis, design alternative assessments, failure mode and effect analysis, tolerance studies, part and material metrology, assembly accuracy and device/system functionality to specification.
- Analyzes first article data and provides recommendations for approvals and/or corrective actions.
- Creates and executes product development evaluation, final validation and early prototype field testing test plans to ensure all product design specifications are met.
- Supports production following engineering and pilot assembly builds for verification of product quality and user acceptance.
- Interfaces with Quality Assurance personnel to develop compliant documentation, reproducible inspection plans, and capable gauging systems.
- Verifies the design with Quality Assurance to audit all critical dimensions and performance requirements during production.
- Leads complex precision plastic and electro-mechanical innovation programs to ensure successful design, development and launch of new, innovative products using a fiscally balanced mix of internal and external resources.
- Proactively develops solutions to program challenges.
- Ensures projects are completed on time, within budget, and meet the users’ needs (i.e., sales, marketing, management, and IRRAS’ Customers) are delighted with the outcome.
- Demonstrates competency in working with highly effective teams across geographically disperse resources, including internationally.
- Is able to contribute to all aspects of a program from inception, through development, validation, manufacturing transfer and scale up then product launch.
- Owns the documentation of program goals, including the detailed Product Requirements and test results.
- May perform additional duties as assigned or directed by management from time to time
- Bachelor of Science Degree in an Engineering discipline from an accredited university or demonstrated ability through practical experience to perform technical and project management responsibilities required in this position.
- High energy and the ability to multi-task across projects.
- 3 to 5 years of demonstrated “hands-on” experience in engineering/technical groups
- Exhibits excellent team participation skills, viewing issues from a cross functional perspective.
- Exhibits strong technical savvy, excellent time and project management skills and a sound problem-solving acumen.
- Ideal candidate will have experience in the medical device industry or similar field with disposable and capital devices.
- Competence in the following is highly desirable:
- DFMEA & PFMEA
- MiniTab or similar statistical analysis software
- Phase based product development process
- Broad root cause and problem-solving methodologies
- Must have solid administrative skills including computer proficiency in Microsoft Project, Word, Excel and PowerPoint.
- Excellent verbal and written communication skills with an ability to interface with all levels of the organization.
REQUIRED INTERPERSONAL SKILLS:
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work with minimal direction.
- Believes in and follows the practices of Filotimia
- Ability to be part of a high-performance team focused on accountability and meeting and exceeding expectations.
- Ability to influence, create and work within cross-functional team environments.
- Assertive, take-charge with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done.
- Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
- Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
- Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
- Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
- Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
- Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
- Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
The physical demands described here are representative of those that must be met by an employee to successfully perform 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 talk or hear. The employee is frequently required to sit.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
- Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee might occasionally lift and/or move up to 20 pounds.
The work environment characteristics 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.
General office environment.
Daily exposure to PCs and networks.
The noise level in the work environment is usually moderate.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
If you are interested in employment at IRRAS, please apply to this job here.