Job Description
JOB PURPOSE:
To design new devices/components and make design changes or improvements to existing devices/components. 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 regulatory requirements are met and that the medical device meets the requirements for its intended use
- Plans and drives execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production
- 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
- Guides the project team through use of design and technology to drive innovation and significantly improve patient outcome
- 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
- 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, dFMEA, and pFMEA (design/process Failure Mode Effects Analysis)
- Evaluates and designs products, parts, or processes for cost efficiency to minimize the cost for patient care
- Coordinates project activities for Commercial Release of expansive product lines and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations
- Leads Core Team to ensure that project phases are completed in a timely manner
- Defines activities for project execution to meet the requirements of the Product Development Process
- Supports request for quotes, 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 concepts, 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)
WORKING CONDITIONS:
Works with minimal supervision from manager. Requires light physical activity performing non-strenuous daily activities
NOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.
Job Tags