Process Dev Engineering (Engineering)
JOB PURPOSE:
To develop catheter process from concept to commercialization or make improvements to existing processes. Leads major programs to bring new designs or design changes through the applicable phases of the Product Development Process.
ESSENTIAL DUTIES:
- Functions as leader for major programs involving all phases of product design and development, leading Core Team through the execution of project activities
- Follows and improves the Product Development Process to ensure that the medical device meets the requirements for its intended use
- Utilize manufacturing processes such as; RF tipping, braiding, and lamination reflow to build proof-of-concept catheter prototypes.
- Employ DFA and DFM principles to guide manufacturing process decisions.
- Plan and drive execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production in a timely manner
- Applies the Risk Management Policy to the development process for identifying hazards, estimating and evaluating associated risks, controlling these risks and monitoring the effectiveness of risk controls
- Strives for improvement to ensure all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability
- Diligently develops product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market Surveillance
- Evaluates and designs processes for cost efficiency
- Oversees creation of detailed sub-assembly and final assembly drawings to serve as design specifications for a medical device
- Develops verification and validation plans for the protocols, test methods, and reports for execution of design verification and validation testing
- Able to navigate completely new medical devices through product requirements, design inputs, design outputs, and verification/validation in traceability matrix
- Introduces design mitigations to significantly reduce the risk profile for the medical device as documented in Risk Management File and pFMEA (process Failure Mode Effects Analysis)
- Defines activities for project execution to meet the requirements of the Product Development Process
- Supports request for quotes technically for manufacturing feasibly, specifically complex devices that vary greatly from predicates
- Upholds Spectrum Plastics Group vision and core values
- Follows all safety guidelines and adheres to safety absolutes
QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required:
- Bachelor's degree in engineering or equivalent experience in a related field.
- 7+ years industry experience
- Proficient in commonly-used manufacturing techniques, practices, and procedures within medical device design and development
- Experience as project manager on a project which involved all phases of product design and development, leading Core Team through the execution of project activities
- Knowledge on developing full-scale project plans
- Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion
- Experience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production
- Can handle financial responsibilities for major programs, such as budget accountability and revenue recognition
- Demonstrated history to problem solve, identify errors and deficiencies and perform research
- High degree of understanding of ISO 13485 requirements for Design Controls
- Ability to apply knowledge to their job function using pre-established guidelines and instructions
- Accuracy, attention to detail, and thoroughness
- Proficient computer skills
- Proficient communications skills
- Ability to comprehend and comply with company safety and quality standards
- Ability to provide oral and written instructions to others
Preferred:
- Master's Degree in Engineering discipline
- Proficiency in Microsoft Project
- Demonstrated ability to complete product design transfers
- Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2)
