Johnson & Johnson companies are equal opportunity employers.
Senior Product Development Engineer, GRQP Trauma-6606140319
Description
DePuy Synthes is currently recruiting for a Senior Product Development Engineer, GRQP Trauma located in West Chester, PA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world.
DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
For First 12 months of role, works to support Synthes Trauma Global Quality Remediation Plan (GRQP). Post GRQP, designs and develops new instruments and implants, utilizing both engineering and project management skills. Primary communication with surgeons and sales force, understanding clinical issues, defining the design parameters to support AO philosophies, and ensuring a quality product is delivered to the customer. Provide mentoring and coaching to junior team members.
POSITION DUTIES & RESPONSIBILITIES:
For first 12 months undertakes Device History File remediation, Design Change Order remediation, New Product Development process improvements, and Risk Management updates; Post GRQP, assumes the trainer/mentor role for associate PD engineers or new PD engineers in the product development process which includes verification and validation activities such as mechanical testing protocols and bioskills lab protocols, utilization of design and drafting standards, and technology transfer to manufacturing; Identifies and investigates new technologies and projects with the guidance of the Group Manager and/or Director of Product Development; Conceptualizes new implant and instrument design based upon current surgical trends and needs; Responsible for development within the high impact projects within the group; Coordinate and lead special tasks assigned by Group Manager and Director of Product Development (i.e. creation of design or manufacturing standards, sales force or training presentations, etc.); Held accountable as designated independent engineer within the department and for other groups and departments as necessary for design reviews and technology transfer; Perform verification/validation activity reviews for the group and department assuring patient, FDA, and surgeon requirements are met for a quality product. Establish and maintain relationships with experts in the field (i.e. surgeons, research scientists, metallurgists, etc.); Maintain awareness of surgical trends through involvement with or support of AO expert groups within the TK system; Able to perform engineering related tasks of Group Manager when the GM is not available; Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times; Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
A minimum of a Bachelor’s degree in Mechanical Engineering is required. A minimum of 6 -8 years of product development or design control experience is required. Experience with metallic implants is an asset. Knowledge of the drug GMPs, QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements is required. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred. Experience with Class I and II medical devices is required. Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and an understanding of GD&T is required. Knowledge of 510(k) submissions process and regulation controls, and/or IDE clinical studies is an asset. Prior project management experience is required. Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience. Prior experience coaching, mentoring, train and developing staff is strongly preferred. Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations. A successful track record of leading and influencing others without authority, participating on cross-functional teams and solid negotiating skills to bring products from concept to launch is required. Must have the ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers and/ or teams across the organization is required. Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required. Knowledge of CAD software (Pro Engineering, Pro-E, Solid Works, AutoCAD, etc.) is required. Willing to work with cadavers and within an Operating Room setting is required. This position will be based in West Chester, PA and requires up to 30% travel, with the potential for international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: R&D Engineering (R&D)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Senior Product Development Engineer, GRQP Trauma-6606140319
Description
DePuy Synthes is currently recruiting for a Senior Product Development Engineer, GRQP Trauma located in West Chester, PA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world.
DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
For First 12 months of role, works to support Synthes Trauma Global Quality Remediation Plan (GRQP). Post GRQP, designs and develops new instruments and implants, utilizing both engineering and project management skills. Primary communication with surgeons and sales force, understanding clinical issues, defining the design parameters to support AO philosophies, and ensuring a quality product is delivered to the customer. Provide mentoring and coaching to junior team members.
POSITION DUTIES & RESPONSIBILITIES:
For first 12 months undertakes Device History File remediation, Design Change Order remediation, New Product Development process improvements, and Risk Management updates; Post GRQP, assumes the trainer/mentor role for associate PD engineers or new PD engineers in the product development process which includes verification and validation activities such as mechanical testing protocols and bioskills lab protocols, utilization of design and drafting standards, and technology transfer to manufacturing; Identifies and investigates new technologies and projects with the guidance of the Group Manager and/or Director of Product Development; Conceptualizes new implant and instrument design based upon current surgical trends and needs; Responsible for development within the high impact projects within the group; Coordinate and lead special tasks assigned by Group Manager and Director of Product Development (i.e. creation of design or manufacturing standards, sales force or training presentations, etc.); Held accountable as designated independent engineer within the department and for other groups and departments as necessary for design reviews and technology transfer; Perform verification/validation activity reviews for the group and department assuring patient, FDA, and surgeon requirements are met for a quality product. Establish and maintain relationships with experts in the field (i.e. surgeons, research scientists, metallurgists, etc.); Maintain awareness of surgical trends through involvement with or support of AO expert groups within the TK system; Able to perform engineering related tasks of Group Manager when the GM is not available; Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times; Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
A minimum of a Bachelor’s degree in Mechanical Engineering is required. A minimum of 6 -8 years of product development or design control experience is required. Experience with metallic implants is an asset. Knowledge of the drug GMPs, QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements is required. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred. Experience with Class I and II medical devices is required. Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and an understanding of GD&T is required. Knowledge of 510(k) submissions process and regulation controls, and/or IDE clinical studies is an asset. Prior project management experience is required. Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience. Prior experience coaching, mentoring, train and developing staff is strongly preferred. Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations. A successful track record of leading and influencing others without authority, participating on cross-functional teams and solid negotiating skills to bring products from concept to launch is required. Must have the ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers and/ or teams across the organization is required. Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required. Knowledge of CAD software (Pro Engineering, Pro-E, Solid Works, AutoCAD, etc.) is required. Willing to work with cadavers and within an Operating Room setting is required. This position will be based in West Chester, PA and requires up to 30% travel, with the potential for international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: R&D Engineering (R&D)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement