Senior Engineer, Manufacturing
This is a unique opportunity for a Senior Engineer to join the newly created Advanced Catheter Engineering New Product Development group at our Draper, Utah site.
This position will allow someone to get in on the shaft catheter business and implement new manufacturing processes and technology resulting in high capacity and a sustainable product line.
They will interact with cross-functional internal and external engineering resources to implement advanced processes and have a meaningful and direct impact on new device introduction.
Key
Responsibilities:
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.
g.
, SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards Evaluate manufacturing processes that could be improved and develop a strategy for implementation Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports Draft, approve, execute, and maintain relevant documentation such as SOPs, specifications, drawings, process sheets, FMEAs, and facilitate validation protocols as necessary to support implementation of equipment projects, as well as new process integrations Collaborate with team leadership in identifying risks and develop contingency plans (i.
e.
schedule slippage).
Ensure that risk mitigation plans are implemented to achieve project timelines.
Analyze and resolve complex Manufacturing and Compliance issues (e.
g.
, CAPA, non-conformances, audit observations) Collaborate with team decision-making, identify and escalate issues when appropriate Develop process requirement specifications, collaborate with outside design firms and work with Operations personnel to establish efficient solution systems Perform other duties and responsibilities as assigned Required
Qualifications:
Bachelor's Degree in an Engineering or Scientific field with 4 years of previous professional experience Required or Master's Degree or equivalent in an Engineering or Scientific field with 3 years of previous professional experience including either industry or industry/education Required or Ph.
D.
or equivalent in an Engineering or Scientific field with industry experience or industry/education Required Preferred
Qualifications:
Experience working in the medical device industry Experience with catheter manufacturing Knowledge of material science and/or extrusion Experience with product design or new product development Experience with validations Knowledge of Solidworks or CAD Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN experience leading to manufacturing efficiency improvement.
Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation.
Effective negotiation skills and ability to work through obstacles effectively Strict attention to detail Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Substantial understanding of processes and equipment used in assigned work Capable of analyzing and solving complex problems in a fast pace environment through innovative thought and experience Strong communication and interpersonal skills Demonstrated use of process excellence methodologies, such as six sigma methodologies.
Adhere to all company rules and requirements (e.
g.
, pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination.
In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Recommended Skills Attention To Detail Auditing Cad Certified Global Meeting Planner Communication Decision Making Estimated Salary: $20 to $28 per hour based on qualifications.
This position will allow someone to get in on the shaft catheter business and implement new manufacturing processes and technology resulting in high capacity and a sustainable product line.
They will interact with cross-functional internal and external engineering resources to implement advanced processes and have a meaningful and direct impact on new device introduction.
Key
Responsibilities:
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.
g.
, SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards Evaluate manufacturing processes that could be improved and develop a strategy for implementation Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports Draft, approve, execute, and maintain relevant documentation such as SOPs, specifications, drawings, process sheets, FMEAs, and facilitate validation protocols as necessary to support implementation of equipment projects, as well as new process integrations Collaborate with team leadership in identifying risks and develop contingency plans (i.
e.
schedule slippage).
Ensure that risk mitigation plans are implemented to achieve project timelines.
Analyze and resolve complex Manufacturing and Compliance issues (e.
g.
, CAPA, non-conformances, audit observations) Collaborate with team decision-making, identify and escalate issues when appropriate Develop process requirement specifications, collaborate with outside design firms and work with Operations personnel to establish efficient solution systems Perform other duties and responsibilities as assigned Required
Qualifications:
Bachelor's Degree in an Engineering or Scientific field with 4 years of previous professional experience Required or Master's Degree or equivalent in an Engineering or Scientific field with 3 years of previous professional experience including either industry or industry/education Required or Ph.
D.
or equivalent in an Engineering or Scientific field with industry experience or industry/education Required Preferred
Qualifications:
Experience working in the medical device industry Experience with catheter manufacturing Knowledge of material science and/or extrusion Experience with product design or new product development Experience with validations Knowledge of Solidworks or CAD Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN experience leading to manufacturing efficiency improvement.
Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation.
Effective negotiation skills and ability to work through obstacles effectively Strict attention to detail Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Substantial understanding of processes and equipment used in assigned work Capable of analyzing and solving complex problems in a fast pace environment through innovative thought and experience Strong communication and interpersonal skills Demonstrated use of process excellence methodologies, such as six sigma methodologies.
Adhere to all company rules and requirements (e.
g.
, pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination.
In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Recommended Skills Attention To Detail Auditing Cad Certified Global Meeting Planner Communication Decision Making Estimated Salary: $20 to $28 per hour based on qualifications.
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