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Senior Product Manager

Summary:

SAM Medical, a leader and innovator in the dynamic world of pre-hospital medicine, is looking for a product leader to be the vital link between customer needs and company growth targets.  This hybrid position, based at the headquarters in Tualatin, OR, reports to the Director of Product Management and the Project Management Office (PMO). The Senior Product Manager will have global product management responsibility for assigned product lines. The Senior Product Manager will also work cross-functionally with all departments to build inputs and marketing requirements for new and existing product lines.

Duties and Responsibilities:  

Upstream product management of the main product categories assigned.  This activity would include but not be limited to the following:

• Developing end user customer requirements for new and existing product development efforts and collaborating cross-functionally with all internal departments for successful product launch efforts
• Cultivate and expand group of KOLs (Key Opinion Leaders) in target markets served to better understand Voice of the Customer to drive product line extensions or new product concepts
• Utilize market analytics to understand market share, total available market, and emerging trends and requirements to feed new product development efforts
• Own customer feedback and input on new product development and line extension projects from product concept up through and into full product launch
• Coordinate with the sales and marketing team to provide all project deliverables in a timely manner for the company’s Stage – Gate Product Development Process
• Coordinate with training department to develop product launch training materials and conduct product training for new product launches as required
• Work closely with the Director of Product Management on related marketing activities as assigned
• Manage and lead the product lifecycle process for assigned product categories.
• Collaborate with marketing team members on downstream marketing activities as appropriate

Managerial Responsibilities:

• None

Required Certifications and Licenses:

• Driver's license
• Passport

Physical Requirements:

• Able to lift 30 lbs.
• Ability to travel up to 20% of the time
• Able to sit for prolonged periods of time

Education and Experience:

• Bachelor’s degree
• 5+ years of marketing and product management experience in healthcare or related field or equivalent combination of marketing and clinical experience in nursing (ER or other), EMS or other related field
• Demonstrated ability to accurately gather customer or end user requirements and create product proposals based on market analytics
• Experience with NPD processes and procedures
• Ability or experience with conducting market research and assessing competitive landscape
• Experience or demonstrated ability in relationship establishment in all markets end users in the medical industry (first responders (EMT/Paramedic), and clinicians
• Strong presentation skills
• Competency and understanding of medical products, channels and industry dynamics
• MBA desirable but not required

Wage Range:

• Based on Experience

Benefits:

As a valued SAM Medical employee, you will be eligible for our excellent benefit package including:

• Medical, Dental, & Vision Insurance
  
• 401K
  
• FSA
  
• Paid Holidays
  
• Vacation and PTO 

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities associated with it. SAM Medical Products management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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QUALITY ENGINEER

The Quality Engineer works as an integral part of the SAM Medical Quality Assurance team responsible for release of high-quality medical products and continued maintenance of a compliant Quality Management System. The QE is the voice of Quality in the new product development process. The QE will serve as a resource to manufacturing to improve product quality, reliability, and process capability. The QE will be leading the identification, documentation, assessment, and correction of post-market product quality issues using risk management and root cause analysis tools. 

Reports to:
Quality Manager 

Key Duties and Responsibilities:

• Provide Quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Compile and analyze quality data using standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities; investigates relevant variables potentially affecting product and processes. Develop recommendations based upon the analysis.
• Establish and support a work environment of continuous improvement that supports SAM Medical’s Quality Policy, Quality System, and the relevant regulations for the areas they support.
• Presents Quality data to Management at periodic reviews of the Quality System.
• Work with R&D and Quality Assurance to create Quality Inspection Plans for components and final product acceptance for new products and existing product lines.
• Supports the First Article inspection program by developing process capability studies and validation plans to ensure expected quality levels for manufactured components are delivered.
• Evaluate, analyze and investigate customer/internal complaints then drive to resolve identified issues.
• Perform CAPA and SCAR investigations in a timely manner for product and process issues to ensure ongoing compliance with SAM Medical specifications and regulatory requirements.
• Collaborate with R&D and Manufacturing to identify, analyze, troubleshoot, and resolve out of specification product or process non-conformance issues.
• Participate in Material Review Boards, identify non-conformance trends and develop technical investigation plans.
• Develop, qualify/certify, and maintain supplier quality development and perform supplier audits. Primary Quality representative for supplier management and resolution of supplier nonconformances.
• Resolve any quality, test, and certification requirements in cooperation with R&D and Materials to assure overall agreement between SAM Medical drawings/ specifications and supplier expectations.
• Collaborate with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
• Promote compliance with company procedures and regulatory requirements for medical device manufacturing. 

Requirements / Knowledge: 

• Five or more years of quality engineering experience in an FDA or other regulated industry.
• BS degree in science, engineering, or manufacturing.
• Prior experience with finished medical devices is required.
• Demonstrated knowledge of quality concepts, statistical analysis and DMAIC.
• Knowledge of international standards used in medical device design and manufacturing
• Experience with developing and guiding process validations (IQ/OQ/PQ)
• Experience with developing and guiding Gage R&R studies
• Strong problem solving and analytical skills with demonstrated knowledge of the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.)
• Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare quality control data and develop statistically valid experiments
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485 are required.
• Knowledgeable about medical device sterilization – ideally Gamma Sterilization.
• Strong interpersonal skills are required.
• Excellent verbal and written communication skills are required
• Project Management experience is preferred
• Ability to work on multiple projects simultaneously
• Certification as a Lead Auditor for ISO 13485 is preferred
• ASQ Certified Quality Engineer preferred
• Green or Black Belt certification is a plus
• Candidate must be results oriented, quick learner, respond to the urgent needs of the Company 

Working Environment: 

• Works generally at a desk in a well-lit, air-conditioned cubicle/office, with low noise levels
• Ability to sit for hours at a time, viewing computer monitor
• Some walking and standing relative to interaction with other company personnel
• Periods of multiple tasks and rapid deadlines may occur 

Work Schedule: 
The position is exempt, full-time days during the hours of normal business operations, work hours may include weekends when necessary. 

Travel:

• Long-distance or air travel is typically less than 20% annually
• Will need to possess a valid passport for international travel 

Physical Requirements:
Routinely lift more than 15-20 pounds. Ability to spend extended periods sitting and using a computer

Benefits:
As a valued SAM Medical employee, you will be eligible for our excellent benefit package including:

• Medical, Dental, & Vision Insurance
• 401K
• FSA
• Paid Holidays
• Vacation and PTO 

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities associated with it. SAM Medical Products management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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Apply Now

Job Title:    Marketing Coordinator
Location:    Onsite at SAM Medical Offices in Tualatin, OR
Reports to:    Director of Marketing

DESCRIPTION  
The focus of this full-time position is to assist the marketing department with regulatory labels, promotions, e-commerce administration, internal communications, and global sales support. This position will operate in a regulated medical device environment with a quality management system. 

KEY DUTIES / ACCOUNTABILITIES

Assist the Director of Marketing with tasks in the following areas:

• Asset Management – Project source files, images, photos, marketing collateral, documents, correspondence
• Graphic Production – Product packaging updates, label updates, print and digital ad updates/creation, email marketing, image adjustments
• Marketing Calendar – Implement/monitor calendar tasks; email campaigns, print and digital advertising, website graphics/promotions, sales promotions
• Photography – Product photography, Employee photos, marketing imagery
• Project Management – Monitor marketing project plans, update/modify as needed
• Regulatory – Ensure marketing assets meet regulatory requirements, update/modify as needed
• Trade Shows – Support trade show marketing
• Training – Support product training efforts, assist in asset development, update/modify assets
• Other – Attend administrative and departmental meetings as required and perform other tasks assigned by Marketing Manager

QUALIFICATIONS, SKILLS, AND COMPETENCIES

• Prior experience as a marketing coordinator or relevant marketing role
• Ability to multi-task and work under pressure to meet deadlines
• Driven and motivated with a willingness to learn
• Critical thinker with strong problem-solving and research skills
• Strong organizational skills and detail oriented
• Excellent communication skills – listening, verbal, written, presentation
• Self-starter and able to independently move projects forward, prioritize tasks, and meet deadlines
• Proficient in Microsoft Office 365, Microsoft Teams
• Experience in Adobe Creative Suite, Smartsheet is a plus
• Project management skills a plus
• Team player

WORKING ENVIRONMENT/PHYSICAL DEMANDS

• Works generally at a desk in a well-lit, air-conditioned cubicle with moderate noise levels
• Regularly spend extended periods of sitting and using a computer and telephone
• Routinely lift more than 10-15lbs
• Periods of multiple tasks and urgent deadlines will occur
• Limited trade show event travel

WORK SCHEDULE

• Full-time days, work hours, may include some weekends as required

COMPENSATION
Commensurate with experience
 
BENEFITS
As a valued SAM Medical employee, you will be eligible for our excellent benefit package including:

• Medical, Dental, & Vision Insurance
• 401K
• FSA
• Paid Holidays
• Vacation and PTO 

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities associated with it. SAM Medical Products management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Apply Now