Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.

We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours. 

The Quality Engineer applies best practices from within the field of quality control to ensure that the materials, components, processes, and manufacturing techniques used produce high quality and reliable products. They review design or process changes for impact to quality, and the design history file.

Nature of Role: Reporting to the Director of Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories

Requirements: 

• Bachelor's degree in a scientific or engineering field is required
• Minimum 5 years' experience in a quality engineering role in the medical, electronics packaging, high reliability, or a related industry with manufacturing & assembly processes
• Strong written and verbal communication skills are required, including proficiency with standard office productivity suite and data analysis software
• ISO Lead Auditor training is preferred
• ASQ CQE preferred
• High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.
• Experience with design review and design control
• Experience with FDA GMP practices, CAPA and non-conforming materials (NCMR) processes
• Ability to travel occasionally to suppliers as required by projects, which may include Asian or other off-shore partners

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

• Successful communication skills, business acumen and assertive decision-making ability
• Flexibility to multi-task and perform a wide range of activities
• Excellent computer skills, including MS Office proficiency
• Self-motivated and capable of working with minimal supervision

Responsibilities: 

• Takes an active role to ensure products meet corporate, industry, and regulatory standards
• Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements
• Evaluates changes to design and/or manufacturing process for impact to DHF. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation.
• Develops manufacturing control plans for internal and outsourced processes. Manages work completed by third party suppliers or contractors, ensuring deliverables meet Ximedica procedures and standard of quality.
• Ensures suppliers are on the approved vendor list, evaluates supplier appropriateness, and audits suppliers if required by Ximedica processes. These may be remote or in person audits.
• Completes component part qualification activities not limited to, but including first articles, cap studies, gage R&R, and implementation of SPC requirements
• Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical, or mechanical
• Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities utilizing knowledge in engineering fields
• Performs internal quality and design control audits
• Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA)
• Supports product/process transfers during pilot and manufacturing builds
• Conducts design for manufacturability reviews and suggests improvements to aid in capability and measurement analysis
• Lead or assist in quality evaluation of returned products and support RMA program as assigned
• Lead, participate in, or coordinate Internal Corrective Action initiatives as assigned
• Participates in the technical review of design input specifications and design documentation for new and existing medical devices as assigned
• Additional support in quality services or quality systems activities as assigned.

Ximedica is a contract design, development and manufacturing company specializing in medical devices, instruments, and technologies. Ximedica participates in the entire development process from initial design exploration to supply of finished goods. Its core competencies include mechanical and electronic design as well as firmware and software implementation. In addition, Ximedica offers design control, compliance-related documentation tracking and offshore sourcing of components and subassemblies.

The Talent Acquisition Manager should have a minimum of 5 years of experience in talent acquisition and be able to develop recruiting strategies and leverage understanding of the business’ workforce planning needs to support talent acquisition strategies to attract and hire a diverse, best-in-class talent for the organization. Reporting to the VP of Human Resources, the Talent Acquisition Manager is responsible for collaborating with internal subject matter experts to oversee the full life cycle recruiting, utilizing standard and creative sourcing, evaluating and screening resumes, completing phone screens & interviews to determine if a selected candidate(s) meets position requirements, and extending offers and closing candidates.

Responsibilities:

• Executes strategic workforce hiring plan for the business by handling requisitions for end-to-end recruitment of internal and external talent
• Partners with Hiring Manager and HR Business Partner in the recruitment and selection process
• Manages a consistent, high volume flow of qualified candidates through active and passive recruitment methods, reviewing qualifications and resumes of potential candidates to qualify their fit for a position
• Evaluates applicants by discussing job requirements and applicant qualifications with managers, interviewing applicants on consistent set of qualifications
• Establishes recruiting requirements by studying organization plans and objectives; meeting with managers to discuss needs
• Builds applicant sources, including building networks to find qualified passive candidates
• Provides input on best sourcing channels and career sites for functional talent; serves as a primary source of staffing and recruitment strategy advice, consultation and education
• Supports talent strategy by presenting diverse interview slates; evaluates profiles of potential candidates and performs assessment of candidates’ knowledge, skills, and aptitudes
• Implements sourcing strategies to attract prospects, maximize talent pipelines, and minimize outside agency costs
• Manages candidate experience, hiring manager satisfaction and other talent acquisition metrics.
• Uses technology for applicant tracking, candidate management, and reporting
• Adheres to EEO and Compliance data and reporting requirements Interact with, and understand the needs of, hiring managers; communicate updates to as needed regarding their active positions

Requirements: High-energy, self-starters with the following qualities are encouraged to apply:

• Minimum 5 years of experience in high volume recruiting environment developing recruiting strategies; prior experience in medical device, life sciences, or technology industry preferred
• Experience with Applicant Tracking Software (ATS) such as ADP, Taleo or other; update ATS to reflect status of candidates and requisitions
• Ability to use technology to improve workflow processes and automate daily tasks.
• Excellent verbal and written communication skills including the ability to articulate complex information in a straightforward manner and the ability to train and guide staff

Ximedica is a contract design, development and manufacturing company specializing in medical devices, instruments, and technologies. Ximedica participates in the entire development process from initial design exploration to supply of finished goods. Its core competencies include mechanical and electronic design as well as firmware and software implementation. In addition, Ximedica offers design control, compliance-related documentation tracking and offshore sourcing of components and subassemblies.

The Training and Development Manager, reporting to the Sr. VP of Operations, is responsible for collaborating with internal subject matter experts to generate effective training materials that can be deployed across the company efficiently. Training material to be generated and managed will include but not limited to business operations, program management, software, quality management system, Leadership and development. The manager is also responsible for the coordination of the new employee on-boarding program and owns the associated continuous improvement initiatives. The manager also assists in the administration of the program for professional development of employees. Depending on the particular training, assisting in deployment of the training is expected and occasional travel may be required.

Requirements: Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities are encouraged to apply:

• Minimum 5 years of experience in training content generation and deployment
• Knowledge of effective training techniques for a multi-generational, cross-site employee workforce
• Successful experience of translating business processes and technical topics into valuable training materials that may be deployed with or without a real-time trainer
• Direct experience with development of web-based training materials is preferred
• Successful written and verbal communication skills
• Get-it-done mentality that is able to drive cross functional teams to accomplish results
• Flexibility to multi-task and perform a wide range of activities
• Excellent computer skills, including use of software for training content generation

Responsibilities:

• Generate content for business operations, program management, software, quality management system, Leadership and development. At the on‑set, a majority of time will be spent to develop training materials for a new software system to manage the Quality document control and training processes.

• Coordination of the new employee on-boarding program. Owns and drives completion of associated continual improvement initiatives.

• Assist in the administration of the program for professional development of employees. Tasks may include collating training and development needs, identifying and arranging for suitable training vendors, and managing the training and development budget

• Deployment of logistics of particular trainings, as assigned.

• Occasionally delivers training as a trainer, as assigned.

The Senior Design Assurance Engineer provides leadership and input to our contract development teams in the design of highly complex medical devices.  They ensure that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and help to ensure successful transfer of the design to manufacturing.  They are responsible for accurate and independent generation and evaluation of Design History File documentation and overall Quality System compliance. They also help guide and mentor other team members in a collaborative environment.

Nature of Role:  Reporting to the Head of Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of design assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.

Requirements:

• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations

• Experience in Risk Management Planning, UFMEAs, DFMEAs, EV, DV, MSAs and ideally PFMEAs, Process Verification & Validation, and Supplier Quality

• Must be able to delegate tasks as lead when there are multiple design assurance members on a program

• Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, vendors, partners, and customers

• Must be able to travel occasionally to meet with customers / project teams
  Education:  Bachelors Degree or higher in Engineering, or a related scientific discipline.
• Experience:  6-10+ years of relevant experience.

Responsibilities:  

• Responsible for establishing, communicating, and mitigating risk throughout the product development process
• Support growth and provide mentorship to junior design assurance team members. Be a leader within the design assurance group.
• Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance to customer and regulatory requirements
• Provides Quality Systems and Design Control guidance to cross-functional development team(s) in approach to verification and documentation tasks
• Create, manage, and/or execute test objectives, test plans and schedules - coordinate test resources for engineering and design verification. Complete test reports.
• Coordinate and support execution of supplier qualification activities
• Participate in design reviews
• Review and revise Quality Management System documentation to keep current with industry standards
• Support internal and external audit activities

The Program Manager has a Bachelor of Science Degree and a minimum of 5 years of experience in consumer product development, diagnostics, and/or medical equipment and device development or its equivalent experience.

Nature of Role:

Reporting to the Director of Program Management, this individual manages and executes program direction in accordance with the client and development team goals. The following key attributes are required:

• Flexibility to perform and manage a wide range of activities and willingness to “wear many hats”
• Outstanding people skills; friendly, confident, competent, great communicator, honest, and sincere
• Must be a dynamic personality and willing to work within a collaborative team environment
• Energetic, proactive self-starter who enjoys challenges and variety

Responsibilities:

General:

• Sound program management skills, including task scheduling, budget tracking
• Develop and Maintain schedule, ensure schedule has been reviewed by internal supervisor. Schedule will include resource needs to accomplish tasks. Schedule and resource needs to be submitted to management at the beginning of the phase and updated on a monthly basis
• Ensure proposal deliverables are completed on time and within budget
• Ensure program is compliant with the Ximedica product development process, including Ximedica’s SOP’s guidelines
• Ensure invoicing is done within the 1^st 5 business days of the following month. Ensure that deposit invoices are submitted prior to start of program.
• Ensure that any out of scope work is approved by either the client and/or internally. Ensure that additional project codes are utilized to track changes. Ensure that each PO has a separate job code
• Advocate and maintain appropriate resource loadings needed to maintain project deliverables, including budget and schedule
• Ensure team members are accurately entering their hours into the accounting system on a weekly basis
• Ensure program profitability
• Conduct post-mortem with team members and appropriate senior management on each phase during the program
• Ability to organize and communicate high-level presentations to clients, clinicians, and participating teams, as necessary
• Develop with team, appropriate presentations of activities during each phase of program. Ensure that each presentation is reviewed internally by management prior to submitting to client/other
• Maintain day-to-day relationships with client companies
• Submit weekly project status dashboards to internal management and/or client
• Ensure meeting agendas are submitted prior to and utilized during meetings
• Demonstrated ability to direct and manage resources, make decisions, solve problem, exercise good judgment & flexibility and maintain budgets and schedule
• Ensure that each team member is aware in writing the time (work effort and duration) allotted for activities
• Coordinate all aspects of program activities, between the client and Ximedica industrial design, engineering, quality, regulatory, testing, documentation, etc.
• Ability to communicate with vendors and to proactively monitor internal resources to ensure all products are developed within cost targets and delivered on schedule
• Ensure Ximedica is meeting the needs of the client and that the device will be successful in the marketplace

Medical Specific:

• Familiarity in the design of complex medical capital equipment as well as disposable devices
• Familiarity with appropriate FDA, QSR, and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge
• Manage the design and development of complex electro-mechanical medical devices and equipment

Other experience:

• Experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, sheet metal fabrication, etc.
• Experience in leading concept generation activities
• Understanding of Human Centered Industrial Design & Usability research activities and their interface with engineering
• Understanding of Mechanical engineering development process utilizing 3D CAD or related engineering software techniques
• Understanding of electronics and software development
• Understanding of Voice of the Customer and User Needs research activities and process