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Form of workJob Description
Benefits:
Description:
Cogmedix provides turnkey manufacturing services to a broad range of medical OEMs, delivering new products to market with rigorous quality control and full regulatory compliance. The Operations Process Engineer (OPE) will provide critical leadership and support to manufacturing operations in an FDA & ISO 13485 regulated, medical device manufacturing facility. Working independently or as part of a team, the Process Engineer role will be responsible for the design and optimization of manufacturing processes through all product life cycle phases. A significant portion of responsibility will be devoted to supporting the design, startup and operation of a high-volume automated assembly line utilizing RF sealing technology and pick/place robots in a controlled environment. The OPE will be an integral part of Operational Excellence at Cogmedix, using statistical techniques to make improvement recommendations, and lead/support CI initiatives/events. In addition, the position will be a key leader in analyzing and improving process cycle times, capacity, and productivity.
Responsibilities:
Responsible for the development and optimization of manufacturing processes from inception through start up, validation & full-scale production.
Perform engineering analysis of process performance and recommend opportunities for improvement with safety, efficiency, and risk mitigation as goals.
Develop preventative and predictive maintenance programs, troubleshoot problems associated with manufacturing processes and write associated technical documentation.
Lead and support Continuous Improvement activities such as Kaizens, Process improvements, and structured problem-solving events.
Design and plan cell layouts for Operation Excellence using lean manufacturing tools and techniques.
Conduct research and testing to develop new and/or improved processes for manufacturing.
Lead or support other engineering functions during IQ, OQ, PQ process validations.
Provide project management and technical support for plantwide process improvement projects.
Sustaining and improvement of established CI programs.
Train/develop equipment technicians & Production Leads for daily operations support.
Act as SME on SPL programs that require automation, tooling design and/or process optimization.
Other duties as assigned.
Qualifications
Essential Requirements:
Requires a BSME (or related engineering discipline) and 5+ years of Manufacturing/Process engineering experience.
Experience with machine based repetitive manufacturing or other processing industry required.
Experience with manufacturing equipment/machinery, automation & controls required. Knowledge of RF welding desirable.
Familiar with controlled environment protocols in an ISO 13485 & FDA compliant facility.
Experience with disposable medical device manufacturing a plus.
Experience programming machine controls using HMI or offline software is highly desirable.
Six Sigma (Green or Black belt) certification and/or expertise in lead manufacturing methods highly desirable.
Experience utilizing DFMA methodologies and developing tools/fixtures for process optimization and waste elimination.
Experience designing manufacturing lines using takt time, capacity analysis and cycle times.
Experience in authoring detailed process work instructions and other procedures.
Position requires a highly motivated self-starter able to work under minimal supervision with excellent technical, analytical, and interpersonal skills.
Must have excellent written and verbal communication skills.
Must be methodical, organized, be able to exercise good judgement, and manage multiple projects and tasks on a concurrent basis.
Adept in MS office tool sets including but not limited to Word, Excel, Visio, MS Project, Access, Power Point.
Experience with SolidWorks and statistical software (such as Minitab) desirable.
Must be able to lead and motivate team members.
Work is performed in a controlled environment or light industrial production area.
While performing the duties of the job, the employee is regularly required to stand for an extended amount of time, walk and reach with hands and arms. Able to lift and move up to 50 pounds.
Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.
Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
- 401(k)
- 401(k) matching
- Competitive salary
Description:
Cogmedix provides turnkey manufacturing services to a broad range of medical OEMs, delivering new products to market with rigorous quality control and full regulatory compliance. The Operations Process Engineer (OPE) will provide critical leadership and support to manufacturing operations in an FDA & ISO 13485 regulated, medical device manufacturing facility. Working independently or as part of a team, the Process Engineer role will be responsible for the design and optimization of manufacturing processes through all product life cycle phases. A significant portion of responsibility will be devoted to supporting the design, startup and operation of a high-volume automated assembly line utilizing RF sealing technology and pick/place robots in a controlled environment. The OPE will be an integral part of Operational Excellence at Cogmedix, using statistical techniques to make improvement recommendations, and lead/support CI initiatives/events. In addition, the position will be a key leader in analyzing and improving process cycle times, capacity, and productivity.
Responsibilities:
Responsible for the development and optimization of manufacturing processes from inception through start up, validation & full-scale production.
Perform engineering analysis of process performance and recommend opportunities for improvement with safety, efficiency, and risk mitigation as goals.
Develop preventative and predictive maintenance programs, troubleshoot problems associated with manufacturing processes and write associated technical documentation.
Lead and support Continuous Improvement activities such as Kaizens, Process improvements, and structured problem-solving events.
Design and plan cell layouts for Operation Excellence using lean manufacturing tools and techniques.
Conduct research and testing to develop new and/or improved processes for manufacturing.
Lead or support other engineering functions during IQ, OQ, PQ process validations.
Provide project management and technical support for plantwide process improvement projects.
Sustaining and improvement of established CI programs.
Train/develop equipment technicians & Production Leads for daily operations support.
Act as SME on SPL programs that require automation, tooling design and/or process optimization.
Other duties as assigned.
Qualifications
Essential Requirements:
Requires a BSME (or related engineering discipline) and 5+ years of Manufacturing/Process engineering experience.
Experience with machine based repetitive manufacturing or other processing industry required.
Experience with manufacturing equipment/machinery, automation & controls required. Knowledge of RF welding desirable.
Familiar with controlled environment protocols in an ISO 13485 & FDA compliant facility.
Experience with disposable medical device manufacturing a plus.
Experience programming machine controls using HMI or offline software is highly desirable.
Six Sigma (Green or Black belt) certification and/or expertise in lead manufacturing methods highly desirable.
Experience utilizing DFMA methodologies and developing tools/fixtures for process optimization and waste elimination.
Experience designing manufacturing lines using takt time, capacity analysis and cycle times.
Experience in authoring detailed process work instructions and other procedures.
Position requires a highly motivated self-starter able to work under minimal supervision with excellent technical, analytical, and interpersonal skills.
Must have excellent written and verbal communication skills.
Must be methodical, organized, be able to exercise good judgement, and manage multiple projects and tasks on a concurrent basis.
Adept in MS office tool sets including but not limited to Word, Excel, Visio, MS Project, Access, Power Point.
Experience with SolidWorks and statistical software (such as Minitab) desirable.
Must be able to lead and motivate team members.
Work is performed in a controlled environment or light industrial production area.
While performing the duties of the job, the employee is regularly required to stand for an extended amount of time, walk and reach with hands and arms. Able to lift and move up to 50 pounds.
Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.
Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
