Minnetronix, Inc.
Job Description
Exceptional People. Hard Problems. Meaningful Careers. Big Impact. Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us. Job Summary: The Senior Process Development Engineer is responsible for technical leadership and timely development and evaluation of new manufacturing processes to support the needs of the customer. This requires representation for the department in inter-company relations and providing technical expertise to internal clients and the customer. Senior Engineers may have direct reports and/or operate in a Lead Engineer capacity, managing resources and/or small to mid-sized projects. Job Duties and Responsibilities: Process Concept Proposes new process/equipment/core technology improvement concepts. Understands how user and patient needs translate to process and functional product outputs. Aids in selection of process improvements to increase UPH, yield, and manufacturability on pre-production and/or production products. Participates in strategic planning and department goal setting Leads phase II and process related quoting activities to support new project costing. Provides guidance on process standards, templates, and best practices. Process Design & Development Translates customer requirements into process specific outputs. Plans and manages the development and evaluation of process assembly steps. Plans, manages, and conducts activities surrounding risk assessment (e.g., FMEA) of product concepts. Participates in risk assessment (e.g., DFMEA) or product concepts and translates customer DFMEA requirements to pFMEA and team. Manages process capability, DOE, and other characterization studies to analyze and report on results using statistical analysis. Completes engineering documentation (e.g., manufacturing and inspection procedures (MIPs), router/BOM updates, etc.). to prepare and finalize documentation before verification and validation testing. Participates in project planning, business case evaluation, and project tracking. Leads customer meetings related to process specifics and process details. Verification & Validation Manages determination of qualification requirements and criteria for new products/processes based on Intricon and customer procedures/requirements. Leads timeline planning and operations resource requests for execution of qualification activities. Prepares and releases verification/validation protocols and reports (IQ, OQ, PQ, etc.) Leads and manages the development of master validation plan (MVP) documentation. Collaborates with other functions to execute project deliverables. Communicates directly with customer to define validation strategy, approach, and constraints. Work Conditions Use manual and light power tools to make and test prototypes. Works in a development lab environment in addition to office. May be in and around a tool shop. May be in a cleanroom or controlled environment area. May travel to customer or vendors for project driven objectives. Working Through Others/Interpersonal Relationships Establishes extensive interdepartmental and interdivisional networks. Has an in-depth understanding of the various organizational interfaces (laboratory, engineering, sales, and marketing) Implements comprehensive educational plans to develop, maintain, and expand state-of-the-art knowledge in functional area. Participates in recruiting and staffing. *Essential Functions QUALIFICATIONS: Education: Bachelor’s degree in mechanical, chemical, bio-medical engineering or similar field of study or equivalent experience Experience: Minimum six (6) years engineer experience in medical device industry or equivalent. Extensive expertise in one or several fields of the technology. Skills: Experience in design controls and Quality System Regulations. Extensive verbal and technical writing skills Proven analytical and problem-solving skills. Strong personal, interpersonal and communication skills Self-initiator in relation to project and/or project teams. Extensive command of the activities required in the product development cycle. Proven ability to coach/mentor people in junior positions. Demonstrate initiative towards introducing new technologies. Comfortable in ambiguity and determining necessary steps for progress. Interest and curiosity in differing points of view Physical Requirements: Physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing duties of this Job, employee is regularly required to use hands to finger, handle, or feel. Employee is frequently required to stand; walk; sit and talk or hear. Employee is occasionally required to reach with hands and arms. Employee must occasionally lift and/or move up to 25 pounds. Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. All positions are responsible for following applicable company policies and procedures as defined by their manager. EEO Statement
Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Working Condition
Must be authorized to work in the United States. Compensation and Total Rewards Package
The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.
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Exceptional People. Hard Problems. Meaningful Careers. Big Impact. Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us. Job Summary: The Senior Process Development Engineer is responsible for technical leadership and timely development and evaluation of new manufacturing processes to support the needs of the customer. This requires representation for the department in inter-company relations and providing technical expertise to internal clients and the customer. Senior Engineers may have direct reports and/or operate in a Lead Engineer capacity, managing resources and/or small to mid-sized projects. Job Duties and Responsibilities: Process Concept Proposes new process/equipment/core technology improvement concepts. Understands how user and patient needs translate to process and functional product outputs. Aids in selection of process improvements to increase UPH, yield, and manufacturability on pre-production and/or production products. Participates in strategic planning and department goal setting Leads phase II and process related quoting activities to support new project costing. Provides guidance on process standards, templates, and best practices. Process Design & Development Translates customer requirements into process specific outputs. Plans and manages the development and evaluation of process assembly steps. Plans, manages, and conducts activities surrounding risk assessment (e.g., FMEA) of product concepts. Participates in risk assessment (e.g., DFMEA) or product concepts and translates customer DFMEA requirements to pFMEA and team. Manages process capability, DOE, and other characterization studies to analyze and report on results using statistical analysis. Completes engineering documentation (e.g., manufacturing and inspection procedures (MIPs), router/BOM updates, etc.). to prepare and finalize documentation before verification and validation testing. Participates in project planning, business case evaluation, and project tracking. Leads customer meetings related to process specifics and process details. Verification & Validation Manages determination of qualification requirements and criteria for new products/processes based on Intricon and customer procedures/requirements. Leads timeline planning and operations resource requests for execution of qualification activities. Prepares and releases verification/validation protocols and reports (IQ, OQ, PQ, etc.) Leads and manages the development of master validation plan (MVP) documentation. Collaborates with other functions to execute project deliverables. Communicates directly with customer to define validation strategy, approach, and constraints. Work Conditions Use manual and light power tools to make and test prototypes. Works in a development lab environment in addition to office. May be in and around a tool shop. May be in a cleanroom or controlled environment area. May travel to customer or vendors for project driven objectives. Working Through Others/Interpersonal Relationships Establishes extensive interdepartmental and interdivisional networks. Has an in-depth understanding of the various organizational interfaces (laboratory, engineering, sales, and marketing) Implements comprehensive educational plans to develop, maintain, and expand state-of-the-art knowledge in functional area. Participates in recruiting and staffing. *Essential Functions QUALIFICATIONS: Education: Bachelor’s degree in mechanical, chemical, bio-medical engineering or similar field of study or equivalent experience Experience: Minimum six (6) years engineer experience in medical device industry or equivalent. Extensive expertise in one or several fields of the technology. Skills: Experience in design controls and Quality System Regulations. Extensive verbal and technical writing skills Proven analytical and problem-solving skills. Strong personal, interpersonal and communication skills Self-initiator in relation to project and/or project teams. Extensive command of the activities required in the product development cycle. Proven ability to coach/mentor people in junior positions. Demonstrate initiative towards introducing new technologies. Comfortable in ambiguity and determining necessary steps for progress. Interest and curiosity in differing points of view Physical Requirements: Physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing duties of this Job, employee is regularly required to use hands to finger, handle, or feel. Employee is frequently required to stand; walk; sit and talk or hear. Employee is occasionally required to reach with hands and arms. Employee must occasionally lift and/or move up to 25 pounds. Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. All positions are responsible for following applicable company policies and procedures as defined by their manager. EEO Statement
Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Working Condition
Must be authorized to work in the United States. Compensation and Total Rewards Package
The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.
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