Halkey-Roberts Corporation
Senior New Product Development Engineer
Halkey-Roberts Corporation, Saint Petersburg, Florida, United States, 33701
Job Summary:The Senior NPD Engineer is responsible for leading new product development activities, along with existing product evaluation and testing across multiple product lines. This position will ensure product requirements and quality standards are satisfied and to help assess how well the product will meet customer needs in terms of functionality and usability.
Duties and Responsibilities:Design and develop innovative products from concept to production that provide a sustained competitive advantageInnovation leadership to drive unique innovative solutions and processesCoordinate cross-functional team member activities to meet specified customer design, manufacturing, and quality requirementsPlan, schedule, and coordinate detailed phases of engineering workDisplay originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniquesCoordinate appropriate communications with customers to facilitate requirements collection/development and project acceptance criteriaRefine technical data received from marketing, sales, customers, and manufacturing team membersWork with internal and external stakeholders to establish and implements strategies consistent with NPD and organizational growth objectivesPerform evaluation testing of prototypes to prove or disprove established hypothesesCreate appropriate project plan/documentation to adequately create a Design History File (DHF) of all projects within the guidelines of company procedures and practicesOversee the development and maintenance of appropriate work instructions and ISO proceduresDevelop test protocols for internal or external use; design and build test equipment; and perform design validation resulting in products that meets customer, design, and manufacturing requirementsLead Technical design reviews across departments. Develop technical solutions to engineering problems using analytical methods such as DOE, correlation studies, and apply statistical analysis for product improvementsMentor and motivate junior engineers while coaching them through activities such as FMEA’s design validation, material and components specifications
Required Knowledge, Skills and Abilities:Innovator: identify technological gaps and conceptualize solutions to meet market needs.Project management: demonstrated ability to manage phase-gate projects and accurately forecast project timelinesKnowledge of plastic injection molding component designKnowledge of plastic injection molding manufacturing techniques and practicesKnowledge of component and assembly design optimized for high volume assembly and manufacturingStrong organization skills: ability to multi-task and prioritize tasks to ensure deadlines are metProven change agent: skill with enabling change and influencing abilitiesMentorship: demonstrate the ability to teach advanced skills/principles to others and provide guidance to less seasoned engineersRapid prototyping methods to evaluate designsKnowledge of patenting processAdvanced working knowledge of standard computer applications including MS Word, Excel, Outlook and PowerPointCommunicate clearly and professionally with internal and external customersAbility to make independent decisions using available resourcesIdentify and resolve problems in a timely manner, gather and analyzes information skillfullyOpen to other’s ideas and exhibits a willingness to try new things.Detail Oriented: demonstrate accuracy and thoroughness; monitor work to ensure quality.
Education and Experience:Bachelor’s Degree in mechanical engineering, biomedical engineering, or related engineering disciplineMaster’s degree or PhD preferred8 - 10 years of related design and development experience in the medical deviceExperience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assembliesHands on experience with Design Control experience including design and process verification and validationSubstantial experience in a Phase-Gate development processSignificant experience in designing production equivalent rapid prototypesDemonstrated knowledge of applied mechanical engineering in product design and evaluationStrong aptitude for hands-on engineering testing and experimentation in a lab environmentUnderstanding and experience in product design and development including the use of tools such as QFD, FEA, Risk Analysis, DFMEA/PFMEA, and GD&TDesign Control experience including design and process verification and validationStrong design skills: proficient in 3D CAD software (SolidWorks preferred)Understanding of CAE tools (FEA, CFD, etc.)Understanding and application of ISO Quality System requirements and FDA regulationsExcellent project management skills. Microsoft Project experience requiredSuperior verbal and written communication skills
Physical Demands:The physical demands described here are representative of those necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable individuals with disabilities to perform the essential functions.
Frequent: Talk, hear, speak, and use hands and fingers to operate a computer, telephone, keyboardFrequent: Specific vision abilities required by this job include close vision requirements due to computer work for full shiftSeldom: Light to moderate lifting is requiredSeldom: Ability to uphold the stress of travelingConstant: Regular, predictable attendance is requiredFrequent: While performing the duties of this job, the employee is required to sit, stand or walk for extended periodsFrequent: Repeatedly lift to waist level and bends to 12 inches off of floor throughout shiftFrequent: This position requires balance, bend/stoop, climb stairs, crawl, crouch, kneel, keyboard/type, push, pull, reach, reach above shoulder, repetitive motion as well as computer/mouse useFrequent: Ability to wear personal protective equipment that may include some or all: safety glasses, lab coat, safety shoes, gloves, hearing protection, hair/beard covering. No make-up or nail polish permitted
Work Environment:The work environment described is representative of what must be met by an employee successfully perform the essential functions of this job.
The physical environment is indoors in a controlled climate manufacturing setting. The noise level may moderate to loud.
Frequent use of personal protective equipment is required to prevent exposure to hazardous materials.
Frequent use of protective clothing is required to maintain clean environment.
Duties and Responsibilities:Design and develop innovative products from concept to production that provide a sustained competitive advantageInnovation leadership to drive unique innovative solutions and processesCoordinate cross-functional team member activities to meet specified customer design, manufacturing, and quality requirementsPlan, schedule, and coordinate detailed phases of engineering workDisplay originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniquesCoordinate appropriate communications with customers to facilitate requirements collection/development and project acceptance criteriaRefine technical data received from marketing, sales, customers, and manufacturing team membersWork with internal and external stakeholders to establish and implements strategies consistent with NPD and organizational growth objectivesPerform evaluation testing of prototypes to prove or disprove established hypothesesCreate appropriate project plan/documentation to adequately create a Design History File (DHF) of all projects within the guidelines of company procedures and practicesOversee the development and maintenance of appropriate work instructions and ISO proceduresDevelop test protocols for internal or external use; design and build test equipment; and perform design validation resulting in products that meets customer, design, and manufacturing requirementsLead Technical design reviews across departments. Develop technical solutions to engineering problems using analytical methods such as DOE, correlation studies, and apply statistical analysis for product improvementsMentor and motivate junior engineers while coaching them through activities such as FMEA’s design validation, material and components specifications
Required Knowledge, Skills and Abilities:Innovator: identify technological gaps and conceptualize solutions to meet market needs.Project management: demonstrated ability to manage phase-gate projects and accurately forecast project timelinesKnowledge of plastic injection molding component designKnowledge of plastic injection molding manufacturing techniques and practicesKnowledge of component and assembly design optimized for high volume assembly and manufacturingStrong organization skills: ability to multi-task and prioritize tasks to ensure deadlines are metProven change agent: skill with enabling change and influencing abilitiesMentorship: demonstrate the ability to teach advanced skills/principles to others and provide guidance to less seasoned engineersRapid prototyping methods to evaluate designsKnowledge of patenting processAdvanced working knowledge of standard computer applications including MS Word, Excel, Outlook and PowerPointCommunicate clearly and professionally with internal and external customersAbility to make independent decisions using available resourcesIdentify and resolve problems in a timely manner, gather and analyzes information skillfullyOpen to other’s ideas and exhibits a willingness to try new things.Detail Oriented: demonstrate accuracy and thoroughness; monitor work to ensure quality.
Education and Experience:Bachelor’s Degree in mechanical engineering, biomedical engineering, or related engineering disciplineMaster’s degree or PhD preferred8 - 10 years of related design and development experience in the medical deviceExperience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assembliesHands on experience with Design Control experience including design and process verification and validationSubstantial experience in a Phase-Gate development processSignificant experience in designing production equivalent rapid prototypesDemonstrated knowledge of applied mechanical engineering in product design and evaluationStrong aptitude for hands-on engineering testing and experimentation in a lab environmentUnderstanding and experience in product design and development including the use of tools such as QFD, FEA, Risk Analysis, DFMEA/PFMEA, and GD&TDesign Control experience including design and process verification and validationStrong design skills: proficient in 3D CAD software (SolidWorks preferred)Understanding of CAE tools (FEA, CFD, etc.)Understanding and application of ISO Quality System requirements and FDA regulationsExcellent project management skills. Microsoft Project experience requiredSuperior verbal and written communication skills
Physical Demands:The physical demands described here are representative of those necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable individuals with disabilities to perform the essential functions.
Frequent: Talk, hear, speak, and use hands and fingers to operate a computer, telephone, keyboardFrequent: Specific vision abilities required by this job include close vision requirements due to computer work for full shiftSeldom: Light to moderate lifting is requiredSeldom: Ability to uphold the stress of travelingConstant: Regular, predictable attendance is requiredFrequent: While performing the duties of this job, the employee is required to sit, stand or walk for extended periodsFrequent: Repeatedly lift to waist level and bends to 12 inches off of floor throughout shiftFrequent: This position requires balance, bend/stoop, climb stairs, crawl, crouch, kneel, keyboard/type, push, pull, reach, reach above shoulder, repetitive motion as well as computer/mouse useFrequent: Ability to wear personal protective equipment that may include some or all: safety glasses, lab coat, safety shoes, gloves, hearing protection, hair/beard covering. No make-up or nail polish permitted
Work Environment:The work environment described is representative of what must be met by an employee successfully perform the essential functions of this job.
The physical environment is indoors in a controlled climate manufacturing setting. The noise level may moderate to loud.
Frequent use of personal protective equipment is required to prevent exposure to hazardous materials.
Frequent use of protective clothing is required to maintain clean environment.