Duration: 24 months contract (Hybrid) Description: The Project Manager, Combination Products Development is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Accessories, Instructions for Use, etc.). The Project Manager ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase. Top 3-5 skills, experience or education required Skill: Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success. Communication: Excellent written and verbal communication skills to manage stakeholders and team members. Risk Management: Expertise in identifying, assessing, and mitigating project risks. Scheduling & Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools. Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements. Education: Required: Bachelor's degree in engineering (mechanical or biomedical engineering). Preferred: Master's degree in engineering or management is preferred but not required. Certification: Project Management Professional (PMP) Certification preferred but not required. Experience: 8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies. Summary of Responsibilities and Accountabilities: The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans and budget defined for the project portfolio. Responsibilities include: Leadership of a portfolio of drug delivery system product development projects Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners Device financial management including budgeting, forecasting and long-range planning of delivery development expenses Representing the R&D organization to cross functional leadership through effective and timely communication Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions Qualifications Required: Bachelor's degree in engineering (mechanical or biomedical engineering). Master's degree in engineering or management is preferred but not required. Certification: Project Management Professional (PMP) Certification preferred, but not required 8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies. Required Skills: Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success. Communication: Excellent written and verbal communication skills to manage stakeholders and team members. Risk Management: Expertise in identifying, assessing, and mitigating project risks. Scheduling & Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools. Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements. Requires an in-depth understanding of the pharmaceutical and device product development cycle. Design history file, project management and product development experience is essential. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.<img src="https://www.jobg8.com/Tracking.aspx?j1PSdIcXzPNrMgno7vn1Ewp" width="0" height="0" />

**Project Manager, Combination Products Development**

Join our team as a Project Manager for Combination Products Development, where you will lead a cross-functional team in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product. This role is essential in ensuring that the strategy and plans defined for assigned programs align with the needs of the patient and customer, as well as the business objectives of the CMC and Product Strategy teams.

**Job Description**

- Lead a portfolio of drug delivery system product development projects.
- Manage external device partners, acting as a key interface and overseeing the project governance process.
- Handle device financial management, including budgeting, forecasting, and long-range planning of delivery development expenses.
- Represent the R&D organization to cross-functional leadership through effective and timely communication.
- Ensure effective use of meetings by clearly defining objectives, agendas, inviting necessary team members, and publishing minutes and actions.

**Requirements**

- Bachelor's degree in engineering (mechanical or biomedical engineering).
- Preferred: Master's degree in engineering or management.
- Project Management Professional (PMP) Certification preferred but not required.
- 8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products.
- Broad experience in design controls, human factors studies, design verification/validation, and usability studies.

**Required Skills**

- Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success.
- Communication: Excellent written and verbal communication skills to manage stakeholders and team members.
- Risk Management: Expertise in identifying, assessing, and mitigating project risks.
- Scheduling & Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools.
- Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements.

**About US Tech Solutions**

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Project Manager III (Design Engineer)

Duration: 4 month contract Schedule: Sun-Wed, 5:00 PM - 3:30 AM Summary The Client Workplace Health & Safety (WHS) team is deeply committed to the safety and well being of our people. WHS sets the strategic direction to provide resources, best practices, and safe environments to proactively manage the health and wellbeing of our workforce. To support these goals, Client is seeking an experienced and dynamic Onsite Medical Representative (OMR) to join our team. In this position, you will work closely with the WHS site manager, WHS specialist, and occasionally the Injury Prevention Specialist (IPS). This includes attending weekly associate safety committee meetings, greeting all new hires for the site or through daily one-on-one interaction. Additionally, the OMR will participate in weekly case management review meetings as necessary. As an OMR, you will independently assess and administer first aid as well as offer guidance to Client Associates (AAs) on both occupational and non-occupational injuries or illnesses. You should be passionate about learning and advocating health and wellness principles to consistently support AAs on a daily basis. You will refer care to outside medical providers as needed, and learn about OSHA regulations, risk, and analysis. The OMR will function as a part of the larger team onsite, assisting with all first aid needs and support safety operations as needed. Responsibilities include but are not limited to: Provide first aid support and make referrals to outside medical providers as necessary. Minimize the AA risk of injury through awareness, education, and proactive engagement. Maintain all records of care provided to AAs. Coordinate and maintain the workers' compensation and return to work programs for AAs with work-related injuries. Provide daily activity logs and end of shift reports. Engage with AAs and leadership on operations floor to provide coaching regarding observed at-risk work habits. Maintain a clean working environment and ensure appropriate medical supply inventory is maintained. Participate in training and certification to facilitate first aid, CPR and AED certifications classes. Maintain all first aid, CPR, AED credentials. Work flexible shifts which could include days, nights, holidays, and/or weekends. Assist with random saliva drug testing protocols. Maintain effective care delivery in emergencies and assist emergency response at the site. For those that do not have an adult First Aid, CPR, AED certification from the American Heart Association or American Red Cross, must obtain within 3 weeks of start date. Basic qualifications: High School or equivalent diploma; AND Current valid Basic Life Support (BLS) certification by an approved emergency cardiac care (ECC) provider; AND Must have one of the following: Current valid Emergency Medical Technician (EMT) OR Paramedic Certification from the Department of Health OR the National Registry of Emergency Medical Technicians (NREMT); OR In the last year, six months job experience in the Military as a Combat Medic (U.S. Army), Field Medic (U.S. Army), Healthcare Specialist (U.S. Army), Hospital Corpsman (U.S. Navy), or Aerospace Medical Service Technician (U.S. Air Force); OR Current active Athletic Trainer Certification, by either the Board of Certification (BOC) or equivalent State Certification. Preferred Qualifications: Certified to teach first aid, CPR, and AED training from American Heart Association or American Red Cross Proficient in Microsoft Office Experience with an industrial wellness program Experience managing musculoskeletal disorders, ergonomics, and coaching on body mechanics Demonstrated work experience with OSHA regulations and Workers Compensation Proficient in digital record keeping About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.<img src="https://www.jobg8.com/Tracking.aspx?j59S52RQbDpsiHRaWnCk3Ac" width="0" height="0" />

**Onsite Medical Representative**

The Client Workplace Health & Safety (WHS) team is deeply committed to the safety and well-being of our people. WHS sets the strategic direction to provide resources, best practices, and safe environments to proactively manage the health and well-being of our workforce. To support these goals, Client is seeking an experienced and dynamic Onsite Medical Representative (OMR) to join our team. In this position, you will work closely with the WHS site manager, WHS specialist, and occasionally the Injury Prevention Specialist (IPS). This includes attending weekly associate safety committee meetings, greeting all new hires for the site or through daily one-on-one interaction. Additionally, the OMR will participate in weekly case management review meetings as necessary. As an OMR, you will independently assess and administer first aid as well as offer guidance to Client Associates (AAs) on both occupational and non-occupational injuries or illnesses. You should be passionate about learning and advocating health and wellness principles to consistently support AAs on a daily basis. You will refer care to outside medical providers as needed and learn about OSHA regulations, risk, and analysis. The OMR will function as a part of the larger team onsite, assisting with all first aid needs and supporting safety operations as needed.

**Job Description**

- Provide first aid support and make referrals to outside medical providers as necessary.
- Minimize the AA risk of injury through awareness, education, and proactive engagement.
- Maintain all records of care provided to AAs.
- Coordinate and maintain the workers' compensation and return to work programs for AAs with work-related injuries.
- Provide daily activity logs and end of shift reports.
- Engage with AAs and leadership on operations floor to provide coaching regarding observed at-risk work habits.
- Maintain a clean working environment and ensure appropriate medical supply inventory is maintained.
- Participate in training and certification to facilitate first aid, CPR, and AED certifications classes.
- Maintain all first aid, CPR, AED credentials.
- Work flexible shifts which could include days, nights, holidays, and/or weekends.
- Assist with random saliva drug testing protocols.
- Maintain effective care delivery in emergencies and assist emergency response at the site.
- For those that do not have an adult First Aid, CPR, AED certification from the American Heart Association or American Red Cross, must obtain within 3 weeks of start date.

**Requirements**

- High School or equivalent diploma.
- Current valid Basic Life Support (BLS) certification by an approved emergency cardiac care (ECC) provider.
- Must have one of the following:
  - Current valid Emergency Medical Technician (EMT) OR Paramedic Certification from the Department of Health OR the National Registry of Emergency Medical Technicians (NREMT).
  - In the last year, six months job experience in the Military as a Combat Medic (U.S. Army), Field Medic (U.S. Army), Healthcare Specialist (U.S. Army), Hospital Corpsman (U.S. Navy), or Aerospace Medical Service Technician (U.S. Air Force).
  - Current active Athletic Trainer Certification by either the Board of Certification (BOC) or equivalent State Certification.

**Preferred Qualifications**

- Certified to teach first aid, CPR, and AED training from American Heart Association or American Red Cross.
- Proficient in Microsoft Office.
- Experience with an industrial wellness program.
- Experience managing musculoskeletal disorders, ergonomics, and coaching on body mechanics.
- Demonstrated work experience with OSHA regulations and Workers Compensation.
- Proficient in digital record keeping.

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